Coccidioidomycosis
Conditions
Keywords
CAP, Coccidioidomycosis, Community Acquired Pneumonia, FLEET, Fluconazole, Parent Study of 16-0008, Pneumonia, Valley Fever
Brief summary
This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by their health care provider for acute CAP will be randomized to receive either placebo or 400 mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia and are compliant with the study intervention.
Detailed description
This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals, aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by their health care provider for acute CAP will be randomized to receive either placebo or 400 mg/day of fluconazole for 42 days. Blood work for serologic determination of coccidioidomycosis infection will be drawn at the time of randomization (Day 1), and again on Days, 22, 29, and 43. On Day 43, subjects will be informed of their treatment assignment and results of serologic testing from Days 1, 22 and 29. At Day 43, those subjects who did not meet the protocol defined case definition for CAP caused by acute coccidioidomycosis and who did not receive fluconazole will be dismissed from the study and referred to a health care provider with the results of their serology testing and their treatment assignment. All subjects who received fluconazole will be evaluated for safety follow up at Day 49. At Day 49, those subjects who did not meet the protocol defined case definition for CAP caused by acute coccidioidomycosis will be dismissed from the study and referred to a health care provider with the results of their serology testing and their treatment assignment. Subjects who did meet the protocol defined case definition for CAP caused by acute coccidioidomycosis infection will be referred to a healthcare provider with the results of their serology testing and their treatment assignment for further treatment as indicated and will be contacted by telephone on Days 90 and 180. The study duration will be approximately 72 months, and the subject participant duration will be from 42 days to approximately 6 months. The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia who are adherent to the study intervention. The secondary objectives are: 1) To assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia regardless of adherence with the study intervention; 2) To assess the clinical response of early empiric antifungal therapy with fluconazole at Day 43 in subjects with coccidioidomycosis pneumonia regardless of adherence with the study intervention; 3) To compare the clinical response and its individual components over time, by treatment group, in subjects with coccidioidomycosis pneumonia; 4) To assess the impact of early empiric antifungal therapy with fluconazole on days lost from work or school and responses to the SF-12v2 and PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in subjects with coccidioidomycosis pneumonia; 5) To assess the effect of early empiric antifungal therapy with fluconazole through Day 43 in subjects with coccidioidomycosis pneumonia on all-cause mortality by treatment group; and 6) To assess whether early empiric antifungal therapy with fluconazole at Day 22 is non-inferior to placebo as defined by clinical response at Day 22 in all randomized subjects, regardless of coccidioidomycosis pneumonia status or adherence with study intervention, with baseline and follow-up FLEET-CAP scores.
Interventions
DRUGFluconazole
Fluconazole is a synthetic triazole antifungal agent. It will be supplied as 200 mg over encapsulated tablets. Each gelatin capsule will contain two-100 mg fluconazole tablets and microcrystalline cellulose for overfill.
OTHERPlacebo
Placebo will be supplied as matching gelatin capsules containing microcrystalline cellulose only. Capsules are the same size, weight, and color as capsules containing fluconazole tablets.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Aged \> / = 18 years and presenting for clinical care in coccidioidomycosis endemic areas. 2. Have a health care provider who has decided to treat community acquired pneumonia with antibacterials. 3. Be able to take and tolerate oral antibacterials/antifungals. 4. Able to understand the study and provide informed consent. 5. Willing and able to comply with study procedures and complete study visits. 6. Willing to allow access to medical records, and medical records are available to the study team. 7. The first dosage of study drug will be administered within 72 hours of presentation for care. 8. Able to swallow large pills. 9. Sexually active female subjects must be of non-childbearing potential\* or, if of childbearing potential, must use a highly effective method of birth control\*\*(captured on the appropriate data collection form). \*Non-childbearing potential is defined as being post-menopausal for at least 18 months or surgically sterile via bilateral oophorectomy or hysterectomy. \*\*Female subjects must avoid becoming pregnant by using one of the following acceptable methods of birth control for 30 days prior to study drug dosing and must be maintained for 30 days after last dose of study drug: i. Intrauterine contraceptive device; OR ii. Oral contraceptives; OR iii. Implanon, Nexplanon, DepoProvera, contraceptive skin patch or NuvaRing; OR iv. Tubal ligation; OR v. Exclusively same-sex relationships. 10. Non-pregnant female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to enrollment and at Visits 02 - 03. 11. Subjects receiving any of the drugs reported to have manageable drug interactions with fluconazole are allowed to be enrolled based on PI clinical judgment.
Exclusion criteria
1. Have recently received an experimental agent\* or participating in or planning to participate in a study involving an experimental agent\*\* while in the active drug administration phase of this study. \*defined as within 30 days prior to enrollment in this study. \*\*(e.g., vaccine, drug, biologic device, blood product, or medication). 2. Present clinical diagnosis of hospital acquired pneumonia (HAP). 3. Documented microbiologically- or serologically-confirmed past infection with coccidioidomycosis. 4. Clinical diagnosis of coccidioidal infection that is of sufficient certainty as to exclude the need for antibacterial therapy. 5. Have a history of systemic antibacterial treatment for this current CAP care episode occurring greater than 4 weeks prior to enrollment\*. \*Receipt of systemic antimicrobial therapy for indications other than respiratory tract infection is permitted. 6. Have a history of systemic antifungal treatment within the 4 weeks prior to enrollment. * A single dose of fluconazole (ex. treatment of vulvovaginal candidiasis) is acceptable and should not exclude subject from study. 7. Long term use\* of high dose oral or parenteral glucocorticoids\*\*; or high-dose inhaled steroids\*\*\* taken within the 4 weeks prior to enrollment. \*defined as \> 8 weeks of daily use. \*\*high dose defined as prednisone \> / = 20 mg total daily dose, or equivalent dose of other glucocorticoids. \*\*\*high dose defined as \> 800 mcg/day of beclomethasone dipropionate or equivalent 8. Have confirmed or suspected immunosuppression as a result of an underlying illness \[other than well controlled HIV infection\], primary immunodeficiency, or treatment, or induction/maintenance use of immunosuppressive agents\*. \*including anti-neoplastic chemotherapy or cytotoxic radiation therapy for cancer, anti-TNF medications, or other immunomodulating agents. 9. History of a solid organ or bone marrow transplant. 10. Have poorly controlled HIV-infection or HIV-infection treated with Lopinavir, Tipranavir, Etravirine or Didanosine. Poorly controlled HIV is defined as HIV RNA \> 50 copies/mm\^3 (or greater than the lower limit of quantification \[LLOQ\] of the local HIV RNA assay if the LLOQ is \> 50) in the 6 months prior to current care episode regardless of whether patient is on antiretroviral therapy or CD4 \< 250 cell/mm\^3. 11. Current diagnosis and/or treatment of active liver disease including abnormal baseline liver function tests as defined as: total bilirubin greater than or equal to 3.0 mg/dL AND either AST greater than or equal to 135 IU/L OR ALT greater than or equal to 150 IU/L. 12. On hemo or peritoneal dialysis or have a creatinine of \> / = 2.0 mg/dL or estimated CrCl \< /= 50 mL/min. 13. History of hypokalemia defined as less than 3.5 mEQ/L on more than one occasion during the 4 weeks prior to enrollment. 14. History of cardiovascular disease with increased risk for torsades de pointes as defined as: i. NYHA Heart Failure Criteria III or greater; OR ii. History of atrial or ventricular dysrhythmias; OR iii. History of structural heart disease (including previously repaired); OR iv.Personal or family history of congenital long QT syndrome. 15. A marked baseline prolongation of the QT/QTc interval defined as a QTc interval \> 450 milliseconds (ms) for male subjects or \> 470ms for female subjects with repeated demonstration\*. \*Subjects without a history of prolonged QTc and an abnormal baseline QTc interval should undergo repeat ECG assessment within screening period prior to randomization (72 hours) to confirm prolongation. If the repeat ECG QTc is within normal limits and less than the parameters above, the subject may be considered for enrollment. 16. Pregnant or lactating females. 17. History of azole intolerance or allergy. 18. Individuals for whom study participation would not be in their best interest, as determined by the clinical investigator. 19. Are taking medications that are contraindicated with concurrent use of fluconazole. 20. Positive point of care HIV test at Day 1 visit consistent with new HIV diagnosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| Number of the Days of School or Work Missed Due to Illness in the ITT Population | Visit 1 (Day 1) through Visit 4 (Day 42-46) | Number of the days of school or work missed due to illness by participant self-report |
| Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population | Visit 1 (Day 1) through Visit 4 (Day 42-46) | Number of the days of school or work missed due to illness by participant self-report |
| Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population | Visit 1 (Day 1) through Visit 4 (Day 42-46) | Number of the days of school or work missed due to illness by participant self-report |
| Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population | Visit 1 (Day 1) through Visit 4 (Day 42-46) | Number of the days of school or work missed due to illness by participant self-report |
| Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population | Visit 1 (Day 1) through Visit 4 (Day 42-46) | Number of the days of school or work missed due to illness by participant self-report |
| The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Visit 2 (Day 20-23) | The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities. |
| Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Visit 2 (Day 20-23) | The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities. |
| Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Visit 2 (Day 20-23) | The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities. |
| Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Visit 2 (Day 20-23) | The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities. |
| Incidence Rate of All-cause Mortality | Day 1 through Day 43 | Mortality information was obtained through medical records or next of kin. |
| The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug | Visit 2 (Day 20-23) | The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. |
| The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | Day 1 | The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health. |
| Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Visit 2 (Day 20-23) | The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between Feb 2016 and May 2018 at community locations in Coccidioides-endemic areas. Participants were adults presenting with community acquired pneumonia (CAP) whose health care provider had made the decision to treat with an antibacterial.
Participants by arm
| Arm | Count |
|---|---|
| Fluconazole Fluconazole was supplied as 200mg over encapsulated tablets. Each gelatin capsule contained two-100mg fluconazole tablets and microcrystalline cellulose for overfill. Fluconazole 400 mg (administered orally as two 200mg capsules) was to be taken once daily for a minimum of 42 days. | 33 |
| Placebo Placebo was supplied as matching gelatin capsules containing microcrystalline cellulose only. In order to maintain the blind, the gelatin capsules were the same size, weight, and color as the capsules containing fluconazole tablets. Placebo (administered orally as two matching placebo capsules) was to be taken once daily for a minimum of 42 days. | 39 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Other Event (Health Related) | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Fluconazole | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 14 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 58 Participants | 33 Participants |
| Age, Continuous | 50.1 years STANDARD_DEVIATION 16.1 | 49.8 years STANDARD_DEVIATION 14.2 | 49.5 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 35 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 37 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Positive for coccidioidomycosis pneumonia | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 57 Participants | 31 Participants |
| Region of Enrollment United States | 33 participants | 72 participants | 39 participants |
| Sex: Female, Male Female | 18 Participants | 36 Participants | 18 Participants |
| Sex: Female, Male Male | 15 Participants | 36 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 39 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 33 | 0 / 39 |
Outcome results
Primary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected capsules.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population | 3 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population | 2 Participants |
Secondary
Incidence Rate of All-cause Mortality
Mortality information was obtained through medical records or next of kin.
Time frame: Day 1 through Day 43
Population: The population includes all participants who took at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluconazole | Incidence Rate of All-cause Mortality | 0 participants |
| Placebo | Incidence Rate of All-cause Mortality | 0 participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 9 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 7 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 15 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 15 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 7 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 11 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 14 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 12 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 15 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 16 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 14 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 16 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 12 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 15 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 12 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 12 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 12 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 7 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 11 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 11 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 15 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Always | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing regular leisure activities w others | Always | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing family activities I want to do | Always | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 2 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing activities with friends I want to do | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population | Trouble doing family activities I want to do | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 4 (Day 42-46)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 16 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 14 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 15 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 16 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 12 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 5 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 6 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 2 (Day 20-23)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 15 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 7 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 7 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 11 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 15 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 12 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 7 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 15 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 4 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 7 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 6 (Day 83-97)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 3 (Day 27-30)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 14 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 4 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 6 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 2 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 5 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 13 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 6 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 11 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 13 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 9 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 10 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 8 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 3 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 7 Participants |
Secondary
Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population
The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities.
Time frame: Visit 7 (Day 173-187)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 1 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 3 Participants |
| Fluconazole | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing regular leisure activities w others | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing family activities I want to do | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Rarely | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Usually | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing usual work (incl work at home) | Always | 1 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Never | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Sometimes | 0 Participants |
| Placebo | Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population | Trouble doing activities with friends I want to do | Usually | 0 Participants |
Secondary
Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluconazole | Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population | 0 days | Standard Deviation 0 |
| Placebo | Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population | 1.5 days | Standard Deviation 5.2 |
Secondary
Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluconazole | Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population | 0 days | Standard Deviation 0 |
| Placebo | Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population | 0.6 days | Standard Deviation 1.8 |
Secondary
Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluconazole | Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population | 0 days | Standard Deviation 0 |
Secondary
Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluconazole | Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population | 0 days | Standard Deviation 0 |
Secondary
Number of the Days of School or Work Missed Due to Illness in the ITT Population
Number of the days of school or work missed due to illness by participant self-report
Time frame: Visit 1 (Day 1) through Visit 4 (Day 42-46)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluconazole | Number of the Days of School or Work Missed Due to Illness in the ITT Population | 0 days | Standard Deviation 0 |
| Placebo | Number of the Days of School or Work Missed Due to Illness in the ITT Population | 1.5 days | Standard Deviation 5.2 |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0.62 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.31 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0.73 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.15 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0.19 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 2.58 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.12 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.46 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.16 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1.97 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0.48 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0.42 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0.13 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.42 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.16 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.19 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0.85 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.41 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0.11 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.26 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0.74 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.48 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.19 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 3.04 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.20 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 3.49 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0.86 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0.74 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0.31 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.6 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.40 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.37 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0.44 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0.08 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.24 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1.36 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0.36 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.12 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.04 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.08 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.20 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0.37 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.30 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0.17 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.10 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.13 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0.23 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0.71 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0.33 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0.17 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0.08 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0.63 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0.42 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0.08 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 2.42 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0.12 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 1.96 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0.48 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0.44 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0.12 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0.44 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0.16 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0.20 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0.80 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0.40 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 2.64 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0.32 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0.72 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0.16 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0.08 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0.16 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0.17 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 3.72 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0.97 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0.76 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0.34 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0.66 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0.45 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0.38 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 1.09 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0.13 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0.35 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0.04 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0.04 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0.09 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0.09 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0.35 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0.17 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0.13 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 1.25 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0.21 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0.38 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0.21 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0.08 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0.08 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0.75 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0.5 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 1.00 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.5 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 2.25 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 3.67 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 1 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 1.00 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.67 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0.33 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0.67 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0.5 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1.00 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 2.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0.5 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 1.00 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0.5 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0.75 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0.5 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0.25 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 1.00 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0.74 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0.26 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0.48 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0.11 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0.19 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0.41 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0.85 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 3.04 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0.74 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 3.49 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0.86 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0.31 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0.60 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0.40 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0.37 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0.20 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0.73 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0.31 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0.19 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0.15 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0.62 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0.46 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0.12 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 2.58 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0.16 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 1.97 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0.48 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0.42 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0.13 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0.42 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0.16 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0.19 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
Secondary
The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0.44 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0.24 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0.08 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0.04 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0.36 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0.12 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0.08 score on a scale |
| Fluconazole | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 1.36 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0.20 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 1.5 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0.23 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0.37 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0.17 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0.30 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0.13 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0.10 score on a scale |
| Placebo | The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 55.3 score on a scale | Standard Deviation 9.8 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 46.9 score on a scale | Standard Deviation 9.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 61.1 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 57.7 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 49.5 score on a scale | Standard Deviation 10.6 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 47.9 score on a scale | Standard Deviation 10.5 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 50.6 score on a scale | Standard Deviation 9.9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 46.2 score on a scale | Standard Deviation 11.5 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 52.4 score on a scale | Standard Deviation 10 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 50.1 score on a scale | Standard Deviation 8.9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 51.3 score on a scale | Standard Deviation 8.7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 46.2 score on a scale | Standard Deviation 11.2 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 48.2 score on a scale | Standard Deviation 10.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 38.6 score on a scale | Standard Deviation 11.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 49.0 score on a scale | Standard Deviation 10.2 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 39.7 score on a scale | Standard Deviation 9.8 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 51.4 score on a scale | Standard Deviation 10 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 45.4 score on a scale | Standard Deviation 11.2 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 49.4 score on a scale | Standard Deviation 10.7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 44.2 score on a scale | Standard Deviation 12 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 51.5 score on a scale | Standard Deviation 13.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 52.9 score on a scale | Standard Deviation 9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 49.5 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 55.5 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 51.5 score on a scale | Standard Deviation 13.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 52.9 score on a scale | Standard Deviation 9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 49.5 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 55.5 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 55.3 score on a scale | Standard Deviation 9.8 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 46.9 score on a scale | Standard Deviation 9.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 61.1 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 57.7 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 50.5 score on a scale | Standard Deviation 10.2 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 48.3 score on a scale | Standard Deviation 10.7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 50.8 score on a scale | Standard Deviation 10.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 45.3 score on a scale | Standard Deviation 11.9 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 53.3 score on a scale | Standard Deviation 10 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 50.5 score on a scale | Standard Deviation 9.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 49.8 score on a scale | Standard Deviation 9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 46.0 score on a scale | Standard Deviation 11 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 49.1 score on a scale | Standard Deviation 10.2 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 39.4 score on a scale | Standard Deviation 11.6 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 47.9 score on a scale | Standard Deviation 9.5 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 39.6 score on a scale | Standard Deviation 10 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 51.7 score on a scale | Standard Deviation 9.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 45.9 score on a scale | Standard Deviation 11.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 49.6 score on a scale | Standard Deviation 10.8 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 43.2 score on a scale | Standard Deviation 11.4 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 54.0 score on a scale | Standard Deviation 11.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 51.6 score on a scale | Standard Deviation 11 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 43.9 score on a scale | Standard Deviation 24.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 60.1 score on a scale | Standard Deviation 3.4 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 51.6 score on a scale | Standard Deviation 8.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 49.6 score on a scale | Standard Deviation 12.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 40.6 score on a scale | Standard Deviation 8.7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 47.4 score on a scale | Standard Deviation 22.1 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 52.0 score on a scale | Standard Deviation 6.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 46.2 score on a scale | Standard Deviation 15.4 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 39.0 score on a scale | Standard Deviation 12.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 42.2 score on a scale | Standard Deviation 10.5 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 51.5 score on a scale | Standard Deviation 13.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 52.9 score on a scale | Standard Deviation 9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 49.5 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 55.5 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 55.3 score on a scale | Standard Deviation 9.8 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 46.9 score on a scale | Standard Deviation 9.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 61.1 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 57.7 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 53.6 score on a scale | Standard Deviation 12.2 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 53.6 score on a scale | Standard Deviation 7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | MCS | 50.2 score on a scale | Standard Deviation 15.5 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population | PCS | 58.9 score on a scale | Standard Deviation 1.7 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 51.5 score on a scale | Standard Deviation 13.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 52.9 score on a scale | Standard Deviation 9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 49.5 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 55.5 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 52.0 score on a scale | Standard Deviation 6.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 46.2 score on a scale | Standard Deviation 15.4 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 37.1 score on a scale | Standard Deviation 8.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 45.3 score on a scale | Standard Deviation 1.9 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 51.6 score on a scale | Standard Deviation 8.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 49.6 score on a scale | Standard Deviation 12.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 43.7 score on a scale | Standard Deviation 9.6 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 60.1 score on a scale | Standard Deviation 1.5 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 54.0 score on a scale | Standard Deviation 11.3 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 51.6 score on a scale | Standard Deviation 11 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 43.9 score on a scale | Standard Deviation 24.3 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 60.1 score on a scale | Standard Deviation 3.4 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 53.6 score on a scale | Standard Deviation 12.2 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 53.6 score on a scale | Standard Deviation 7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 50.2 score on a scale | Standard Deviation 15.5 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 58.9 score on a scale | Standard Deviation 1.7 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 55.3 score on a scale | Standard Deviation 9.8 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 46.9 score on a scale | Standard Deviation 9.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | MCS | 61.1 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population | PCS | 57.7 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 49.5 score on a scale | Standard Deviation 10.6 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 47.9 score on a scale | Standard Deviation 10.5 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 50.6 score on a scale | Standard Deviation 9.9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 46.2 score on a scale | Standard Deviation 11.5 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 52.4 score on a scale | Standard Deviation 10 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 50.1 score on a scale | Standard Deviation 8.9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 51.3 score on a scale | Standard Deviation 8.7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 46.2 score on a scale | Standard Deviation 11.2 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 51.5 score on a scale | Standard Deviation 13.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 52.9 score on a scale | Standard Deviation 9 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 49.5 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 55.5 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 55.3 score on a scale | Standard Deviation 9.8 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 46.9 score on a scale | Standard Deviation 9.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 61.1 score on a scale | — |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 57.7 score on a scale | — |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 48.2 score on a scale | Standard Deviation 10.1 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 38.6 score on a scale | Standard Deviation 11.1 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 49.0 score on a scale | Standard Deviation 10.2 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 39.7 score on a scale | Standard Deviation 9.8 |
Secondary
The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 51.4 score on a scale | Standard Deviation 10 |
| Fluconazole | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 45.4 score on a scale | Standard Deviation 11.2 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 49.4 score on a scale | Standard Deviation 10.7 |
| Placebo | The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 44.2 score on a scale | Standard Deviation 12 |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 2 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 2 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 2 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 2 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 3 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 2 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0.5 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Total FLEET CAP Score | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0.5 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Dyspnea | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Total FLEET CAP Score | 0.5 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fever | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population | Fatigue | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 2.00 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 2.00 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 4 (Day 42-46)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
Secondary
The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 3 (Day 27-30)
Population: The Intent-to-Treat (ITT) population includes all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 1 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0 score on a scale |
| Fluconazole | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 2 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Hypoxia | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Total FLEET CAP Score | 1 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Cough | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fatigue | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Chest Pain | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Dyspnea | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Sputum Production | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Night Sweats | 0 score on a scale |
| Placebo | The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population | Fever | 0 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 54.9 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 46.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 50.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 46.0 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 59.2 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 50.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 61.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 57.7 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 57.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 49.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 55.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 53.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 54.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 48.6 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 54.5 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 52.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 52.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 47.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 50.0 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 39.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | MCS | 49.6 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population | PCS | 39.1 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 54.9 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 48.3 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 50.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 45.3 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 59.2 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 50.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 61.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 57.7 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 57.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 49.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 55.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 57.2 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 54.0 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 49.6 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 48.2 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 55.6 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 52.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 53.3 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 46.9 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: The All-Randomized PP population includes all participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 51.1 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 39.7 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | MCS | 47.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population | PCS | 39.2 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 54.5 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 53.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 36.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 59.0 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 58.8 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 56.7 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 50.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 58.9 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 57.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 49.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 55.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 59.2 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 50.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 61.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 57.7 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 52.7 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 51.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 37.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 45.3 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 58.8 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 56.7 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | MCS | 43.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population | PCS | 60.1 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 54.5 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 53.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 43.7 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 60.1 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 52.7 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 51.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 37.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 45.3 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 58.8 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 56.7 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 43.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 60.1 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 58.8 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 56.7 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 50.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 58.9 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 57.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 49.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 55.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take \>=80% of their expected pills.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 59.2 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 50.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | MCS | 61.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population | PCS | 57.7 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 1
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 50.0 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 39.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 49.6 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 39.1 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 180
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 59.2 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 50.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 61.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 57.7 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 90
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 57.2 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 49.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 55.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 43
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 56.4 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 53.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 54.1 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 48.6 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 29
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 54.5 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 52.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 52.9 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 47.5 score on a scale |
Secondary
The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population
The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.
Time frame: Day 22
Population: The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 54.9 score on a scale |
| Fluconazole | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 46.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | MCS | 50.5 score on a scale |
| Placebo | The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population | PCS | 46.0 score on a scale |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: Intent-to-Treat (ITT) population - This efficacy analysis population includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug | 20 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug | 22 Participants |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: The population includes all participants who took at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication | 20 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication | 22 Participants |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time frame: Visit 2 - Visit 4 (Day 20-46)
Population: The population includes all participants who took at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication | 25 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication | 28 Participants |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population | 20 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population | 22 Participants |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time frame: Visit 2 - Visit 4 (Day 20-46)
Population: All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population | 25 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population | 28 Participants |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.
Time frame: Visit 2 (Day 20-23)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population | 3 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population | 2 Participants |
Secondary
The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.
Time frame: Visit 2 - Visit 4 (Day 20-46)
Population: Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluconazole | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population | 4 Participants |
| Placebo | The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population | 2 Participants |