Virus Diseases
Conditions
Keywords
acute, uncomplicated influenza, Danirixin, oseltamivir
Brief summary
Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation \[CD11b\] expression in response to chemokine \[C-X-C motif\] ligand 1 \[CXCL1\] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin \[DNX\]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the remaining eligibility criteria for those subjects with a positive result on the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health Private Limited.
Interventions
DRUGGSK1325756 (Danirixin)
It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use
DRUGPlacebo To Match GSK1325756
It will be supplied as capsule shaped white film coated placebo tablet for oral use
It will be supplied as size 0 Swedish Orange capsule containing 75 mg Oseltamivir phosphate and overfill of pre-gelatinized starch for oral use
DRUGPlacebo To Match Oseltamivir Phosphate
It will be supplied as size 0 Swedish Orange capsule containing pre-gelatinized starch and magnesium stearate for oral use
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 64 years of age inclusive, at the time of signing the informed consent; * Onset of influenza-like illness symptoms within 48 hours prior to study enrollment. Onset of symptoms is defined as the time when the subject's temperature was measured as elevated (\>=38.0°C \[\>=100.4°F\]) OR the time when the subject first experienced at least one symptom (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, or fatigue); * Subjects have an oral temperature \>=38.0°C (\>=100.4°F) at screening visit or history of feeling feverish within the 24 hours prior to screening visit; * At least one respiratory symptom (cough, sore throat, nasal congestion) and at least one systemic symptom (headache, body aches and pain, fatigue) due to influenza infection; * A positive influenza rapid antigen test; * Body weight \>60 Kilogram (kg) for men and \>45 kg for women; and Body Mass Index (BMI) between 19 to 35 kilogram per meters squared (kg/m\^2), inclusive; * Male or Female subjects could be eligible if : Male subjects with female partners of child-bearing potential must comply with the following contraception requirements from the time of first dose of study medication until at least 36 hours (five half-lives) of study medication after the last dose of study medication: Vasectomy with documentation of azoospermia; Male condom plus partner use of one of the following contraceptive options: Contraceptive subdermal implant; Intrauterine device or intrauterine system; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring ; Percutaneous contraceptive patches; This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception; * Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies Non-reproductive potential defined as: Pre-menopausal females with one of the following: documented Tubal ligation; Documented Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Reproductive potential agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from the time of screening, during dosing, and until at least 36 hrs after the last dose of study medication and completion of the follow-up visit. GSK List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) meeting GSK criteria of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis. Contraceptive subdermal implant; Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. \- Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol.
Exclusion criteria
\- Subject defined as being at high risk of complications from influenza infection according to the World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) and other Influenza Viruses: Pregnant women; Persons of any age with chronic pulmonary disease (e.g. Mild persistent, Moderate or severe asthma, Chronic Obstruction Pulmonary Disease \[COPD\], cystic fibrosis, bronchiectasis); Persons of any age with chronic cardiac disease (e.g. congestive cardiac failure); * Persons with metabolic disorders (e.g. diabetes); Persons with chronic renal disease, chronic hepatic disease, certain neurological conditions (including neuromuscular, neurocognitive and seizure disorders, but not including autism spectrum disorders); Hemoglobinopathies, or immunosuppression, whether due to primary immunosuppressive conditions, such as Human Immunodeficiency Virus (HIV) infection, or secondary conditions, such as immunosuppressive medication or malignancy; * Subjects in whom treatment with an influenza antiviral is considered essential; * Severity of illness requiring or anticipated to require in-hospital care; * Pulse Oximetry levels \<92% (at rest on room air) at screening or requirement for supplemental oxygen; * Any complication of respiratory tract infection, signs of severe or progressive disease, or worsening of any pre-existing medical condition at the time of enrollment, that, in the opinion of the investigator, would place the subject at an unreasonably increased risk of participation in this study; * Suspicion or confirmation of bacterial infection (e.g. otitis media, sinusitis, bronchitis, focal pneumonia) or who are requiring oral or systemic antibiotics within one week before enrollment; * Women who are pregnant as determined by a positive urine human chorionic gonadotrophin (hCG) test prior to dosing or women who are breastfeeding; * Current or chronic documented history of liver disease (including Hepatitis A, B, or C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); In this case documented refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records). In questionable cases the subject cannot be enrolled; * Corrected QT interval (QTc) \>450 millisecond (msec) or QTc \>480 msec in subjects with Bundle Branch Block. * Subjects currently using or expected to use: oral or injectable Cytochrome P450 3A4 (CYP3A4) or Breast Cancer Resistance Protein (BCRP) substrates with a narrow therapeutic index, or oral or systemic glucocorticoids during the study period; Antacids can be used but should not be taken for at least 3 hours preceding and 2 hours after administration of study drug; proton pump inhibitors and histamine H2-receptor antagonists are prohibited from the screening visit until 12 hours after completion of the final dose of study treatment. * Subjects who have taken an approved or investigational anti-influenza medication (e.g., oseltamivir, zanamivir, peramivir, laninamivir, amantadine, rimantidine, ribavirin) within the past 4 weeks before enrollment; * Subjects who received the live attenuated influenza virus vaccine within the past 21 days; * Subjects treated with systemic steroids or immunosuppressants within 2 weeks of study start. * History of alcohol/drug abuse within 6 months of the study start; * Consumption of \>3 alcoholic units for males and females over the past 24 hours. One unit is equivalent to 8 grams of alcohol: a half-pint (\ 240 milliliter \[mL\]) of beer; 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits. * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period; * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer); * Exposure to more than four investigational medicinal products within 12 months prior to the first dosing day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With DRE of Interest-associated Antibiotic Use | Up to Day 28/withdrawal | Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant. |
| Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | Up to Day 28/withdrawal | The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline. |
| Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | Up to Day 28/withdrawal | The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline. |
| Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1) and up to Day 28/withdrawal | Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Vital Signs- Heart Rate (HR) | Baseline (Day 1) and up to Day 28/withdrawal | Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Vital Signs- Respiration Rate (RR) | Baseline (Day 1) and up to Day 28/withdrawal | Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Vital Signs- Temperature | Baseline (Day 1) and up to Day 28/withdrawal | Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | Baseline (Day 1) and up to Day 28/withdrawal | Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline (Day 1) and up to Day 28/withdrawal | 12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Number of Participants With Disease Related Events (DREs) of Interest | Up to Day 28/withdrawal | Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Day 28/withdrawal | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. |
| Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Baseline (Day 1) and up to Day 28/withdrawal | Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Hematology Parameters- Hemoglobin | Baseline (Day 1) and up to Day 28/withdrawal | Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Hematology Parameters- Hematocrit | Baseline (Day 1) and up to Day 28/withdrawal | Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Baseline (Day 1) and up to Day 28/withdrawal | Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Baseline (Day 1) and up to Day 28/withdrawal | Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Baseline (Day 1) and up to Day 28/withdrawal | Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Baseline (Day 1) and up to Day 28/withdrawal | Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | Baseline (Day 1) and up to Day 28/withdrawal | Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Baseline (Day 1) and up to Day 28/withdrawal | Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline (Day 1) and up to Day 28/withdrawal | Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Urinalysis Parameters- Urine pH | Baseline (Day 1), Day 5 and Day 28/withdrawal | Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Baseline (Day 1), Day 5 and Day 28/withdrawal | Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | Up to Day 28/withdrawal | The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Afebrile Participants Over Time Post Initiation of Treatment | Up to Day 28/withdrawal | Afebrile participants were defined as participants with oral temperature \<=37.2 degree Celsius, \<=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature \<=37.2 degree Celsius or \<=99 degree Fahrenheit for 24 hours. |
| Number of Participants Who Used Relief Medication | Up to Day 28/withdrawal | Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. |
| Number of Hospital Admissions Due to Influenza Infection | Up to Day 28/withdrawal | Number of participants admitted in hospital due to influenza infection was recorded. |
| Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14 | Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Up to Day 14 | Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline. |
| Total Dose of Relief Medication | Up to Day 28/withdrawal | Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented. |
| Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14 | Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline. |
| Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Up to Day 14 | Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline. |
| Time to Resolution of Fever Over Time Post Initiation of Treatment | Up to Day 28/withdrawal | Time to resolution of fever was defined as the time when oral temperature was \<= 37.2 degree Celsius (\<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature \<=37.2 degree Celsius or \<=99 degree Fahrenheit for 24 hours. |
Countries
Australia, South Africa, United States
Participant flow
Recruitment details
A total of 45 healthy adult participants with acute, uncomplicated influenza were enrolled. The study was conducted from 01-June 2015 to 25-April-2016 at 17 centres in 3 countries.
Pre-assignment details
A total of 288 participants were screened for this study. Of these, 243 participants were screen failures and 45 were randomized. The reasons for screen failure included: not meeting inclusion/exclusion criteria (238 participants), lost to follow up (1 participant), investigator discretion (1 participant) and withdrew consent (43 participants).
Participants by arm
| Arm | Count |
|---|---|
| Danirixin (DNX) 75 mg Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days | 15 |
| Placebo (PBO) Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days | 7 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days | 16 |
| Oseltamivir (OSV) 75 mg Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days | 7 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Danirixin (DNX) 75 mg | Placebo (PBO) | Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Oseltamivir (OSV) 75 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.9 Years STANDARD_DEVIATION 13.4 | 33.4 Years STANDARD_DEVIATION 11.56 | 42.6 Years STANDARD_DEVIATION 11.53 | 36.3 Years STANDARD_DEVIATION 9.83 | 38.6 Years STANDARD_DEVIATION 12.04 |
| Race/Ethnicity, Customized African American/African Heritage | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 11 Participants | 5 Participants | 13 Participants | 6 Participants | 35 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants | 2 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 9 Participants | 5 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 7 | 0 / 16 | 0 / 7 |
| other Total, other adverse events | 1 / 15 | 2 / 7 | 3 / 16 | 0 / 7 |
| serious Total, serious adverse events | 1 / 15 | 0 / 7 | 0 / 16 | 0 / 7 |
Outcome results
Primary
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)
Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 3 | 7.9 International Units per litre (IU/L) | Standard Deviation 28.12 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 5 | -5.4 International Units per litre (IU/L) | Standard Deviation 10.96 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 8 | -4.4 International Units per litre (IU/L) | Standard Deviation 8.3 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 28/withdrawal | -2.8 International Units per litre (IU/L) | Standard Deviation 9.06 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 3 | -5.0 International Units per litre (IU/L) | Standard Deviation 6.59 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 5 | 4.2 International Units per litre (IU/L) | Standard Deviation 15.27 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 8 | 2.9 International Units per litre (IU/L) | Standard Deviation 3.92 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 28/withdrawal | 2.5 International Units per litre (IU/L) | Standard Deviation 5 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 3 | 6.3 International Units per litre (IU/L) | Standard Deviation 22.53 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 5 | 0.9 International Units per litre (IU/L) | Standard Deviation 4.1 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 8 | -0.8 International Units per litre (IU/L) | Standard Deviation 5.48 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 28/withdrawal | -0.2 International Units per litre (IU/L) | Standard Deviation 6.75 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 3 | 9.3 International Units per litre (IU/L) | Standard Deviation 28.87 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 5 | 7.4 International Units per litre (IU/L) | Standard Deviation 22.36 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 8 | 3.3 International Units per litre (IU/L) | Standard Deviation 11.11 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 28/withdrawal | -7.6 International Units per litre (IU/L) | Standard Deviation 17.6 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 5 | 2.4 International Units per litre (IU/L) | Standard Deviation 7.18 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 3 | 2.9 International Units per litre (IU/L) | Standard Deviation 5.87 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 28/withdrawal | -1.1 International Units per litre (IU/L) | Standard Deviation 5.79 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 28/withdrawal | -1.9 International Units per litre (IU/L) | Standard Deviation 4.18 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 8 | 7.4 International Units per litre (IU/L) | Standard Deviation 8.12 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 5 | 2.4 International Units per litre (IU/L) | Standard Deviation 4.76 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 8 | -0.9 International Units per litre (IU/L) | Standard Deviation 8.32 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 8 | 3.4 International Units per litre (IU/L) | Standard Deviation 4.54 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 3 | -0.1 International Units per litre (IU/L) | Standard Deviation 4.14 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 8 | 9.1 International Units per litre (IU/L) | Standard Deviation 10.98 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 28/withdrawal | 4.9 International Units per litre (IU/L) | Standard Deviation 7.43 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 5 | -1.9 International Units per litre (IU/L) | Standard Deviation 6.12 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 3 | 1.0 International Units per litre (IU/L) | Standard Deviation 4.08 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 28/withdrawal | 2.4 International Units per litre (IU/L) | Standard Deviation 9.69 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 5 | 5.0 International Units per litre (IU/L) | Standard Deviation 6.58 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 3 | -5.0 International Units per litre (IU/L) | Standard Deviation 5.48 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 5 | 0.9 International Units per litre (IU/L) | Standard Deviation 10.7 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 3 | 0.1 International Units per litre (IU/L) | Standard Deviation 5.25 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 5 | 0.8 International Units per litre (IU/L) | Standard Deviation 5.14 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 8 | 2.7 International Units per litre (IU/L) | Standard Deviation 15.18 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 28/withdrawal | -2.9 International Units per litre (IU/L) | Standard Deviation 11.84 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 28/withdrawal | -3.5 International Units per litre (IU/L) | Standard Deviation 10.62 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 3 | -0.9 International Units per litre (IU/L) | Standard Deviation 4.6 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 5 | -2.8 International Units per litre (IU/L) | Standard Deviation 8.33 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 8 | 1.5 International Units per litre (IU/L) | Standard Deviation 7.5 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 8 | -3.3 International Units per litre (IU/L) | Standard Deviation 7.55 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 28/withdrawal | -4.9 International Units per litre (IU/L) | Standard Deviation 7.62 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 3 | -4.5 International Units per litre (IU/L) | Standard Deviation 6.52 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 5 | -4.5 International Units per litre (IU/L) | Standard Deviation 8.83 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 3 | 0.9 International Units per litre (IU/L) | Standard Deviation 3.45 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 8 | 2.9 International Units per litre (IU/L) | Standard Deviation 9.32 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 28/withdrawal | -3.8 International Units per litre (IU/L) | Standard Deviation 7.94 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 28/withdrawal | -0.6 International Units per litre (IU/L) | Standard Deviation 15.44 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 28/withdrawal | -12.8 International Units per litre (IU/L) | Standard Deviation 23.64 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 8 | 0.8 International Units per litre (IU/L) | Standard Deviation 8.56 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 3 | -7.2 International Units per litre (IU/L) | Standard Deviation 9.04 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 5 | 0.2 International Units per litre (IU/L) | Standard Deviation 5.63 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 8 | -11.0 International Units per litre (IU/L) | Standard Deviation 20.65 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 3 | -2.6 International Units per litre (IU/L) | Standard Deviation 3.13 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 5 | -5.8 International Units per litre (IU/L) | Standard Deviation 5.26 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 3 | -8.4 International Units per litre (IU/L) | Standard Deviation 8.38 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 5 | -9.4 International Units per litre (IU/L) | Standard Deviation 5.94 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT: Day 5 | -11.8 International Units per litre (IU/L) | Standard Deviation 12.5 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 8 | -10.4 International Units per litre (IU/L) | Standard Deviation 8.91 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT: Day 8 | 0.2 International Units per litre (IU/L) | Standard Deviation 10.5 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 3 | -7.2 International Units per litre (IU/L) | Standard Deviation 4.49 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP: Day 28/withdrawal | -1.6 International Units per litre (IU/L) | Standard Deviation 9.84 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT) | AST: Day 28/withdrawal | -9.8 International Units per litre (IU/L) | Standard Deviation 11.48 |
Primary
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein
Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 28/withdrawal | -3.7 Grams per Litre (G/L) | Standard Deviation 3.41 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 8 | -1.8 Grams per Litre (G/L) | Standard Deviation 2.75 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 8 | -1.3 Grams per Litre (G/L) | Standard Deviation 2.92 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 3 | -1.9 Grams per Litre (G/L) | Standard Deviation 2.84 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 3 | -1.9 Grams per Litre (G/L) | Standard Deviation 2.12 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 28/withdrawal | -1.6 Grams per Litre (G/L) | Standard Deviation 2.21 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 5 | -1.8 Grams per Litre (G/L) | Standard Deviation 1.9 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 5 | -1.9 Grams per Litre (G/L) | Standard Deviation 2.2 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 5 | -1.0 Grams per Litre (G/L) | Standard Deviation 2.08 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 8 | 0.4 Grams per Litre (G/L) | Standard Deviation 2.88 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 28/withdrawal | -1.0 Grams per Litre (G/L) | Standard Deviation 2.94 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 3 | -2.3 Grams per Litre (G/L) | Standard Deviation 4.61 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 3 | -1.7 Grams per Litre (G/L) | Standard Deviation 2.87 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 8 | -0.3 Grams per Litre (G/L) | Standard Deviation 2.5 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 28/withdrawal | 0.4 Grams per Litre (G/L) | Standard Deviation 1.62 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 5 | -1.3 Grams per Litre (G/L) | Standard Deviation 3.25 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 3 | -2.3 Grams per Litre (G/L) | Standard Deviation 3.15 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 8 | -1.7 Grams per Litre (G/L) | Standard Deviation 4.12 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 3 | -2.8 Grams per Litre (G/L) | Standard Deviation 4.55 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 28/withdrawal | -3.2 Grams per Litre (G/L) | Standard Deviation 4.14 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 5 | -2.3 Grams per Litre (G/L) | Standard Deviation 4.37 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 8 | -1.4 Grams per Litre (G/L) | Standard Deviation 5.77 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 5 | -2.9 Grams per Litre (G/L) | Standard Deviation 5.54 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 28/withdrawal | -1.5 Grams per Litre (G/L) | Standard Deviation 2.24 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 28/withdrawal | -1.0 Grams per Litre (G/L) | Standard Deviation 5.24 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 3 | -3.0 Grams per Litre (G/L) | Standard Deviation 4.42 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 5 | -2.6 Grams per Litre (G/L) | Standard Deviation 1.95 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 8 | -0.4 Grams per Litre (G/L) | Standard Deviation 3.36 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Albumin: Day 28/withdrawal | 0.2 Grams per Litre (G/L) | Standard Deviation 3.49 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 3 | -4.4 Grams per Litre (G/L) | Standard Deviation 5.32 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 5 | -4.0 Grams per Litre (G/L) | Standard Deviation 4.06 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein | Total protein: Day 8 | -2.2 Grams per Litre (G/L) | Standard Deviation 5.07 |
Primary
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 8 | 0.6 Millimoles per Liter (MMOL/L) | Standard Deviation 3.1 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 5 | -0.029 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0917 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 8 | -0.010 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0842 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 28/withdrawal | -0.019 Millimoles per Liter (MMOL/L) | Standard Deviation 0.1077 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 3 | 0.1 Millimoles per Liter (MMOL/L) | Standard Deviation 2.74 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 5 | 0.4 Millimoles per Liter (MMOL/L) | Standard Deviation 2.35 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 3 | -0.036 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0735 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 28/withdrawal | -0.4 Millimoles per Liter (MMOL/L) | Standard Deviation 2.59 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 3 | 0.28 Millimoles per Liter (MMOL/L) | Standard Deviation 1.084 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 5 | 0.13 Millimoles per Liter (MMOL/L) | Standard Deviation 1.084 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 8 | 0.20 Millimoles per Liter (MMOL/L) | Standard Deviation 1.301 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 28/withdrawal | 0.27 Millimoles per Liter (MMOL/L) | Standard Deviation 1.221 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 3 | -0.12 Millimoles per Liter (MMOL/L) | Standard Deviation 0.351 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 5 | -0.07 Millimoles per Liter (MMOL/L) | Standard Deviation 0.401 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 8 | 0.08 Millimoles per Liter (MMOL/L) | Standard Deviation 0.353 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 28/withdrawal | -0.04 Millimoles per Liter (MMOL/L) | Standard Deviation 0.455 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 3 | 0.5 Millimoles per Liter (MMOL/L) | Standard Deviation 1.77 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 5 | 0.3 Millimoles per Liter (MMOL/L) | Standard Deviation 2.82 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 8 | 0.9 Millimoles per Liter (MMOL/L) | Standard Deviation 2.64 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 28/withdrawal | -0.3 Millimoles per Liter (MMOL/L) | Standard Deviation 1.82 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 3 | 0.31 Millimoles per Liter (MMOL/L) | Standard Deviation 0.956 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 5 | 0.47 Millimoles per Liter (MMOL/L) | Standard Deviation 0.83 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 8 | 0.90 Millimoles per Liter (MMOL/L) | Standard Deviation 1.563 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 28/withdrawal | 0.60 Millimoles per Liter (MMOL/L) | Standard Deviation 1.091 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 28/withdrawal | 0.96 Millimoles per Liter (MMOL/L) | Standard Deviation 2.082 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 3 | 0.13 Millimoles per Liter (MMOL/L) | Standard Deviation 0.411 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 28/withdrawal | 0.099 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0334 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 8 | 0.17 Millimoles per Liter (MMOL/L) | Standard Deviation 1.081 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 5 | -0.19 Millimoles per Liter (MMOL/L) | Standard Deviation 1.194 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 5 | 0.16 Millimoles per Liter (MMOL/L) | Standard Deviation 0.428 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 3 | 0.23 Millimoles per Liter (MMOL/L) | Standard Deviation 1.68 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 3 | 0.1 Millimoles per Liter (MMOL/L) | Standard Deviation 2.41 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 5 | 0.9 Millimoles per Liter (MMOL/L) | Standard Deviation 1.07 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 8 | 0.21 Millimoles per Liter (MMOL/L) | Standard Deviation 0.285 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 8 | 0.053 Millimoles per Liter (MMOL/L) | Standard Deviation 0.072 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 28/withdrawal | 0.07 Millimoles per Liter (MMOL/L) | Standard Deviation 0.419 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 3 | -0.31 Millimoles per Liter (MMOL/L) | Standard Deviation 0.888 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 5 | 0.13 Millimoles per Liter (MMOL/L) | Standard Deviation 1.529 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 28/withdrawal | 0.6 Millimoles per Liter (MMOL/L) | Standard Deviation 2.99 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 5 | 0.019 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0672 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 28/withdrawal | 1.1 Millimoles per Liter (MMOL/L) | Standard Deviation 3.13 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 8 | -0.16 Millimoles per Liter (MMOL/L) | Standard Deviation 1.042 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 8 | -0.1 Millimoles per Liter (MMOL/L) | Standard Deviation 1.95 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 8 | 0.3 Millimoles per Liter (MMOL/L) | Standard Deviation 1.7 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 3 | 0.020 Millimoles per Liter (MMOL/L) | Standard Deviation 0.037 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 28/withdrawal | 0.71 Millimoles per Liter (MMOL/L) | Standard Deviation 2.685 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 3 | 0.9 Millimoles per Liter (MMOL/L) | Standard Deviation 2.34 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 5 | 1.1 Millimoles per Liter (MMOL/L) | Standard Deviation 1.86 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 8 | -0.13 Millimoles per Liter (MMOL/L) | Standard Deviation 1.669 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 8 | 0.4 Millimoles per Liter (MMOL/L) | Standard Deviation 2.67 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 28/withdrawal | -0.5 Millimoles per Liter (MMOL/L) | Standard Deviation 2.44 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 3 | 0.51 Millimoles per Liter (MMOL/L) | Standard Deviation 1.385 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 5 | 0.29 Millimoles per Liter (MMOL/L) | Standard Deviation 1.904 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 3 | 0.29 Millimoles per Liter (MMOL/L) | Standard Deviation 1.046 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 28/withdrawal | 0.6 Millimoles per Liter (MMOL/L) | Standard Deviation 2.5 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 28/withdrawal | 0.43 Millimoles per Liter (MMOL/L) | Standard Deviation 1.909 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 3 | 0.01 Millimoles per Liter (MMOL/L) | Standard Deviation 0.237 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 5 | 0.11 Millimoles per Liter (MMOL/L) | Standard Deviation 0.317 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 5 | 0.32 Millimoles per Liter (MMOL/L) | Standard Deviation 1.197 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 8 | 0.15 Millimoles per Liter (MMOL/L) | Standard Deviation 0.223 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 28/withdrawal | 0.14 Millimoles per Liter (MMOL/L) | Standard Deviation 0.422 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 28/withdrawal | 1.19 Millimoles per Liter (MMOL/L) | Standard Deviation 0.91 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 3 | 1.4 Millimoles per Liter (MMOL/L) | Standard Deviation 1.64 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 5 | 0.7 Millimoles per Liter (MMOL/L) | Standard Deviation 2.63 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 8 | 0.82 Millimoles per Liter (MMOL/L) | Standard Deviation 1.05 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 3 | -0.046 Millimoles per Liter (MMOL/L) | Standard Deviation 0.1015 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 5 | -0.033 Millimoles per Liter (MMOL/L) | Standard Deviation 0.1079 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 8 | 1.5 Millimoles per Liter (MMOL/L) | Standard Deviation 2.33 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 8 | 0.030 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0994 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 28/withdrawal | 0.031 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0842 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 3 | 0.3 Millimoles per Liter (MMOL/L) | Standard Deviation 2.5 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 5 | -0.5 Millimoles per Liter (MMOL/L) | Standard Deviation 2.45 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 8 | 0.32 Millimoles per Liter (MMOL/L) | Standard Deviation 1.134 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 3 | -0.24 Millimoles per Liter (MMOL/L) | Standard Deviation 1.328 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 28/withdrawal | -1.2 Millimoles per Liter (MMOL/L) | Standard Deviation 1.64 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 3 | -0.092 Millimoles per Liter (MMOL/L) | Standard Deviation 0.1101 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 8 | 0.48 Millimoles per Liter (MMOL/L) | Standard Deviation 0.733 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 5 | 1.30 Millimoles per Liter (MMOL/L) | Standard Deviation 2.374 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 5 | -1.4 Millimoles per Liter (MMOL/L) | Standard Deviation 3.21 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 5 | -0.052 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0642 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 3 | -1.8 Millimoles per Liter (MMOL/L) | Standard Deviation 2.77 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 3 | 0.62 Millimoles per Liter (MMOL/L) | Standard Deviation 0.782 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 28/withdrawal | 1.6 Millimoles per Liter (MMOL/L) | Standard Deviation 1.34 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 8 | 0.004 Millimoles per Liter (MMOL/L) | Standard Deviation 0.1178 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 5 | -0.88 Millimoles per Liter (MMOL/L) | Standard Deviation 1.413 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 8 | 0.02 Millimoles per Liter (MMOL/L) | Standard Deviation 0.409 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 8 | 2.4 Millimoles per Liter (MMOL/L) | Standard Deviation 1.67 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 28/withdrawal | 0.24 Millimoles per Liter (MMOL/L) | Standard Deviation 0.635 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Day 28/withdrawal | 0.66 Millimoles per Liter (MMOL/L) | Standard Deviation 1.324 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 5 | 0.08 Millimoles per Liter (MMOL/L) | Standard Deviation 0.572 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | CO2 / Bicarbonate: Day 8 | -0.2 Millimoles per Liter (MMOL/L) | Standard Deviation 1.1 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 3 | 2.0 Millimoles per Liter (MMOL/L) | Standard Deviation 1.87 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Day 3 | -0.12 Millimoles per Liter (MMOL/L) | Standard Deviation 0.396 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Day 28/withdrawal | 0.22 Millimoles per Liter (MMOL/L) | Standard Deviation 0.76 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Day 28/withdrawal | 0.098 Millimoles per Liter (MMOL/L) | Standard Deviation 0.1274 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Day 5 | 1.8 Millimoles per Liter (MMOL/L) | Standard Deviation 2.39 |
Primary
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 3 | -1.0 Micromole per Liter (UMOL/L) | Standard Deviation 2.3 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 5 | -0.5 Micromole per Liter (UMOL/L) | Standard Deviation 0.83 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 8 | 0.1 Micromole per Liter (UMOL/L) | Standard Deviation 0.73 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin:Day 28/withdrawal | 0.1 Micromole per Liter (UMOL/L) | Standard Deviation 1.23 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 3 | -0.3 Micromole per Liter (UMOL/L) | Standard Deviation 0.88 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 5 | -1.2 Micromole per Liter (UMOL/L) | Standard Deviation 2.73 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 8 | -0.9 Micromole per Liter (UMOL/L) | Standard Deviation 1.99 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin:Day 28/withdrawal | 0.1 Micromole per Liter (UMOL/L) | Standard Deviation 3.45 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 3; | -1.47 Micromole per Liter (UMOL/L) | Standard Deviation 7.891 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 5 | -4.38 Micromole per Liter (UMOL/L) | Standard Deviation 6.33 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 8 | -5.79 Micromole per Liter (UMOL/L) | Standard Deviation 7.262 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 28/withdrawal | -2.54 Micromole per Liter (UMOL/L) | Standard Deviation 5.166 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 3 | -15.1 Micromole per Liter (UMOL/L) | Standard Deviation 31.18 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 5 | -18.0 Micromole per Liter (UMOL/L) | Standard Deviation 27.46 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 8 | 20.8 Micromole per Liter (UMOL/L) | Standard Deviation 48.26 |
| Danirixin (DNX) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 28/withdrawal | 30.1 Micromole per Liter (UMOL/L) | Standard Deviation 47.4 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 5 | -2.7 Micromole per Liter (UMOL/L) | Standard Deviation 6.37 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 3; | -4.39 Micromole per Liter (UMOL/L) | Standard Deviation 6.733 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 28/withdrawal | -0.4 Micromole per Liter (UMOL/L) | Standard Deviation 48.19 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 28/withdrawal | -4.99 Micromole per Liter (UMOL/L) | Standard Deviation 12.99 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 8 | -14.3 Micromole per Liter (UMOL/L) | Standard Deviation 53.04 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 5 | -7.39 Micromole per Liter (UMOL/L) | Standard Deviation 7.24 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 8 | -0.1 Micromole per Liter (UMOL/L) | Standard Deviation 1.46 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 8 | -10.70 Micromole per Liter (UMOL/L) | Standard Deviation 10.266 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 3 | -2.0 Micromole per Liter (UMOL/L) | Standard Deviation 7.46 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 8 | -0.9 Micromole per Liter (UMOL/L) | Standard Deviation 6.72 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin:Day 28/withdrawal | -0.1 Micromole per Liter (UMOL/L) | Standard Deviation 1.21 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 5 | -0.6 Micromole per Liter (UMOL/L) | Standard Deviation 1.13 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 3 | -9.9 Micromole per Liter (UMOL/L) | Standard Deviation 42.57 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin:Day 28/withdrawal | -0.3 Micromole per Liter (UMOL/L) | Standard Deviation 6.13 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 5 | -47.4 Micromole per Liter (UMOL/L) | Standard Deviation 39.09 |
| Placebo (PBO) | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 3 | 0.0 Micromole per Liter (UMOL/L) | Standard Deviation 1.73 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 5 | 0.0 Micromole per Liter (UMOL/L) | Standard Deviation 2.56 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 3 | -1.6 Micromole per Liter (UMOL/L) | Standard Deviation 2.1 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 5 | -16.3 Micromole per Liter (UMOL/L) | Standard Deviation 45.05 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 8 | 0.5 Micromole per Liter (UMOL/L) | Standard Deviation 3.09 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin:Day 28/withdrawal | 0.5 Micromole per Liter (UMOL/L) | Standard Deviation 3.11 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 28/withdrawal | 12.5 Micromole per Liter (UMOL/L) | Standard Deviation 45.09 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 3; | -6.58 Micromole per Liter (UMOL/L) | Standard Deviation 12.081 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 5 | -10.16 Micromole per Liter (UMOL/L) | Standard Deviation 14.06 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 8 | 0.9 Micromole per Liter (UMOL/L) | Standard Deviation 27.41 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 8 | -8.87 Micromole per Liter (UMOL/L) | Standard Deviation 13.815 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 28/withdrawal | -8.24 Micromole per Liter (UMOL/L) | Standard Deviation 11.771 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 3 | -0.5 Micromole per Liter (UMOL/L) | Standard Deviation 0.74 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 5 | -0.5 Micromole per Liter (UMOL/L) | Standard Deviation 0.74 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 3 | -15.1 Micromole per Liter (UMOL/L) | Standard Deviation 39.17 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 8 | -0.1 Micromole per Liter (UMOL/L) | Standard Deviation 0.83 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin:Day 28/withdrawal | -0.1 Micromole per Liter (UMOL/L) | Standard Deviation 0.83 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 28/withdrawal | 40.6 Micromole per Liter (UMOL/L) | Standard Deviation 63.5 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin:Day 28/withdrawal | 2.0 Micromole per Liter (UMOL/L) | Standard Deviation 2.45 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 8 | 0.0 Micromole per Liter (UMOL/L) | Standard Deviation 1.41 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 3 | 0.2 Micromole per Liter (UMOL/L) | Standard Deviation 0.45 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 5 | -54.8 Micromole per Liter (UMOL/L) | Standard Deviation 33.69 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 8 | 2.2 Micromole per Liter (UMOL/L) | Standard Deviation 3.49 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 3 | -45.8 Micromole per Liter (UMOL/L) | Standard Deviation 36.03 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin: Day 5 | 0.2 Micromole per Liter (UMOL/L) | Standard Deviation 0.45 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 3 | -0.8 Micromole per Liter (UMOL/L) | Standard Deviation 1.79 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 5 | -11.12 Micromole per Liter (UMOL/L) | Standard Deviation 9.955 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Total Bilirubin: Day 5 | 1.0 Micromole per Liter (UMOL/L) | Standard Deviation 1.41 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 8 | -10.32 Micromole per Liter (UMOL/L) | Standard Deviation 5.273 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Uric acid: Day 8 | -13.0 Micromole per Liter (UMOL/L) | Standard Deviation 69.07 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 3; | -8.14 Micromole per Liter (UMOL/L) | Standard Deviation 11.291 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Direct Bilirubin:Day 28/withdrawal | 0.0 Micromole per Liter (UMOL/L) | Standard Deviation 0 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Creatinine: Day 28/withdrawal | -5.34 Micromole per Liter (UMOL/L) | Standard Deviation 5.49 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameters
12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 3 | -5.8 Millisecond (msec) | Standard Deviation 123.37 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 28/withdrawal | 58.2 Millisecond (msec) | Standard Deviation 94.94 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 3 | 3.1 Millisecond (msec) | Standard Deviation 25.9 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 28/withdrawal | 18.9 Millisecond (msec) | Standard Deviation 19.35 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF: Day 3 | 4.5 Millisecond (msec) | Standard Deviation 21.76 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF:Day 28/withdrawal | 11.0 Millisecond (msec) | Standard Deviation 14.1 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 3 | 4.1 Millisecond (msec) | Standard Deviation 25.69 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 28/withdrawal | 6.6 Millisecond (msec) | Standard Deviation 15.25 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 3 | 2.4 Millisecond (msec) | Standard Deviation 6.47 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 28/withdrawal | 3.1 Millisecond (msec) | Standard Deviation 6.33 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 3 | 1.5 Millisecond (msec) | Standard Deviation 4.45 |
| Danirixin (DNX) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 28/withdrawal | -1.3 Millisecond (msec) | Standard Deviation 5.29 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF: Day 3 | 18.8 Millisecond (msec) | Standard Deviation 13.9 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 3 | 14.3 Millisecond (msec) | Standard Deviation 11.93 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 3 | 25.0 Millisecond (msec) | Standard Deviation 19.86 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 28/withdrawal | 9.3 Millisecond (msec) | Standard Deviation 11.87 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 28/withdrawal | -5.7 Millisecond (msec) | Standard Deviation 12.47 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 3 | -5.4 Millisecond (msec) | Standard Deviation 20.25 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 3 | -5.6 Millisecond (msec) | Standard Deviation 6.47 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 28/withdrawal | 17.0 Millisecond (msec) | Standard Deviation 22.12 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 28/withdrawal | 76.9 Millisecond (msec) | Standard Deviation 151.52 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF:Day 28/withdrawal | 24.8 Millisecond (msec) | Standard Deviation 11.73 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 28/withdrawal | 35.9 Millisecond (msec) | Standard Deviation 20.36 |
| Placebo (PBO) | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 3 | 49.4 Millisecond (msec) | Standard Deviation 75.29 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 28/withdrawal | 0.6 Millisecond (msec) | Standard Deviation 8.77 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 28/withdrawal | 25.3 Millisecond (msec) | Standard Deviation 39.96 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 3 | -0.5 Millisecond (msec) | Standard Deviation 6.14 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF: Day 3 | 6.5 Millisecond (msec) | Standard Deviation 12.89 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF:Day 28/withdrawal | 11.0 Millisecond (msec) | Standard Deviation 18.07 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 28/withdrawal | 3.5 Millisecond (msec) | Standard Deviation 14.03 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 3 | 0.3 Millisecond (msec) | Standard Deviation 12.63 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 3 | 0.4 Millisecond (msec) | Standard Deviation 10.53 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 28/withdrawal | 3.0 Millisecond (msec) | Standard Deviation 13.47 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 3 | 83.0 Millisecond (msec) | Standard Deviation 144.39 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 28/withdrawal | 107.4 Millisecond (msec) | Standard Deviation 195.56 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 3 | 17.7 Millisecond (msec) | Standard Deviation 28.78 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF: Day 3 | 24.6 Millisecond (msec) | Standard Deviation 13.03 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcF:Day 28/withdrawal | 4.3 Millisecond (msec) | Standard Deviation 5.31 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 28/withdrawal | 11.1 Millisecond (msec) | Standard Deviation 16.79 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 3 | 39.2 Millisecond (msec) | Standard Deviation 200.77 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 28/withdrawal | 2.5 Millisecond (msec) | Standard Deviation 5.27 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 3 | 1.9 Millisecond (msec) | Standard Deviation 8.92 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QT Interval: Day 3 | 30.7 Millisecond (msec) | Standard Deviation 38.72 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 28/withdrawal | 0.1 Millisecond (msec) | Standard Deviation 7.16 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | RR Interval: Day 28/withdrawal | 41.2 Millisecond (msec) | Standard Deviation 103.82 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | PR Interval: Day 3 | 2.3 Millisecond (msec) | Standard Deviation 10.52 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QRS Duration: Day 28/withdrawal | 0.3 Millisecond (msec) | Standard Deviation 4.09 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Electrocardiogram (ECG) Parameters | QTcB: Day 3 | 20.9 Millisecond (msec) | Standard Deviation 8.83 |
Primary
Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count
Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 28/withdrawal | 0.030 Giga cells per litre (GI/L) | Standard Deviation 0.1335 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 3 | -1.62 Giga cells per litre (GI/L) | Standard Deviation 1.949 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 8 | -0.008 Giga cells per litre (GI/L) | Standard Deviation 0.0634 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 3 | -0.011 Giga cells per litre (GI/L) | Standard Deviation 0.0511 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 3 | 0.093 Giga cells per litre (GI/L) | Standard Deviation 0.6701 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 3 | 0.017 Giga cells per litre (GI/L) | Standard Deviation 0.0929 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 8 | 0.463 Giga cells per litre (GI/L) | Standard Deviation 2.0336 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 5 | -0.94 Giga cells per litre (GI/L) | Standard Deviation 2.408 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 5 | 0.557 Giga cells per litre (GI/L) | Standard Deviation 0.7137 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 5 | 0.034 Giga cells per litre (GI/L) | Standard Deviation 0.1048 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 3 | -9.5 Giga cells per litre (GI/L) | Standard Deviation 16.13 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 3 | -1.614 Giga cells per litre (GI/L) | Standard Deviation 2.1846 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 8 | 0.716 Giga cells per litre (GI/L) | Standard Deviation 0.7584 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 8 | 1.14 Giga cells per litre (GI/L) | Standard Deviation 2.676 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils:Day 28/withdrawal | -0.217 Giga cells per litre (GI/L) | Standard Deviation 2.2068 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 28/withdrawal | 28.3 Giga cells per litre (GI/L) | Standard Deviation 38.74 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 28/withdrawal | 0.564 Giga cells per litre (GI/L) | Standard Deviation 0.5969 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 5 | 16.4 Giga cells per litre (GI/L) | Standard Deviation 22.92 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 28/withdrawal | -0.007 Giga cells per litre (GI/L) | Standard Deviation 0.0517 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 28/withdrawal | -0.061 Giga cells per litre (GI/L) | Standard Deviation 0.1785 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 3 | -0.117 Giga cells per litre (GI/L) | Standard Deviation 0.1524 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 8 | 0.074 Giga cells per litre (GI/L) | Standard Deviation 0.1248 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 8 | 64.3 Giga cells per litre (GI/L) | Standard Deviation 45.02 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 28/withdrawal | 0.31 Giga cells per litre (GI/L) | Standard Deviation 2.31 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 5 | -0.175 Giga cells per litre (GI/L) | Standard Deviation 0.2817 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 5 | -1.371 Giga cells per litre (GI/L) | Standard Deviation 2.111 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 5 | -0.009 Giga cells per litre (GI/L) | Standard Deviation 0.0569 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 8 | -0.104 Giga cells per litre (GI/L) | Standard Deviation 0.231 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 28/withdrawal | 1.56 Giga cells per litre (GI/L) | Standard Deviation 1.992 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 3 | 4.3 Giga cells per litre (GI/L) | Standard Deviation 17.68 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 8 | -0.830 Giga cells per litre (GI/L) | Standard Deviation 2.0826 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 5 | 6.7 Giga cells per litre (GI/L) | Standard Deviation 21.7 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 8 | 0.49 Giga cells per litre (GI/L) | Standard Deviation 1.842 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 8 | 62.1 Giga cells per litre (GI/L) | Standard Deviation 58.12 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 3 | 0.026 Giga cells per litre (GI/L) | Standard Deviation 0.0477 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 28/withdrawal | 47.7 Giga cells per litre (GI/L) | Standard Deviation 40.13 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 5 | 0.017 Giga cells per litre (GI/L) | Standard Deviation 0.0427 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 5 | -0.39 Giga cells per litre (GI/L) | Standard Deviation 1.676 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 3 | -1.64 Giga cells per litre (GI/L) | Standard Deviation 0.879 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 5 | 0.035 Giga cells per litre (GI/L) | Standard Deviation 0.0846 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 3 | -0.002 Giga cells per litre (GI/L) | Standard Deviation 0.0377 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 5 | -1.223 Giga cells per litre (GI/L) | Standard Deviation 2.2278 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 8 | 0.078 Giga cells per litre (GI/L) | Standard Deviation 0.1332 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils:Day 28/withdrawal | -0.217 Giga cells per litre (GI/L) | Standard Deviation 2.071 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 28/withdrawal | 0.163 Giga cells per litre (GI/L) | Standard Deviation 0.2016 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 3 | 0.778 Giga cells per litre (GI/L) | Standard Deviation 0.5904 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 8 | 0.013 Giga cells per litre (GI/L) | Standard Deviation 0.0356 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 3 | -2.276 Giga cells per litre (GI/L) | Standard Deviation 1.5252 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 5 | 1.038 Giga cells per litre (GI/L) | Standard Deviation 0.7784 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 8 | 1.275 Giga cells per litre (GI/L) | Standard Deviation 0.8948 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 28/withdrawal | -0.011 Giga cells per litre (GI/L) | Standard Deviation 0.223 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 28/withdrawal | 1.619 Giga cells per litre (GI/L) | Standard Deviation 0.7884 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 3 | -0.178 Giga cells per litre (GI/L) | Standard Deviation 0.197 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 28/withdrawal | 0.003 Giga cells per litre (GI/L) | Standard Deviation 0.0287 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 8 | -0.097 Giga cells per litre (GI/L) | Standard Deviation 0.1425 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 5 | -0.128 Giga cells per litre (GI/L) | Standard Deviation 0.1631 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 3 | -1.791 Giga cells per litre (GI/L) | Standard Deviation 1.958 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 3 | -0.008 Giga cells per litre (GI/L) | Standard Deviation 0.0196 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 5 | -0.007 Giga cells per litre (GI/L) | Standard Deviation 0.0172 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 8 | 0.005 Giga cells per litre (GI/L) | Standard Deviation 0.019 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 28/withdrawal | 0.030 Giga cells per litre (GI/L) | Standard Deviation 0.052 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 3 | -0.012 Giga cells per litre (GI/L) | Standard Deviation 0.1378 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 5 | 0.012 Giga cells per litre (GI/L) | Standard Deviation 0.1856 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 8 | 0.036 Giga cells per litre (GI/L) | Standard Deviation 0.1416 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 28/withdrawal | 0.032 Giga cells per litre (GI/L) | Standard Deviation 0.1432 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 3 | 0.463 Giga cells per litre (GI/L) | Standard Deviation 0.5443 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 5 | 0.813 Giga cells per litre (GI/L) | Standard Deviation 0.6445 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 8 | 0.918 Giga cells per litre (GI/L) | Standard Deviation 0.9233 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 28/withdrawal | 0.903 Giga cells per litre (GI/L) | Standard Deviation 0.6779 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 3 | -0.105 Giga cells per litre (GI/L) | Standard Deviation 0.1927 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 5 | -0.090 Giga cells per litre (GI/L) | Standard Deviation 0.2479 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 3 | -6.1 Giga cells per litre (GI/L) | Standard Deviation 17.68 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 5 | 13.7 Giga cells per litre (GI/L) | Standard Deviation 31.5 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 8 | 53.3 Giga cells per litre (GI/L) | Standard Deviation 61.73 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 28/withdrawal | 19.2 Giga cells per litre (GI/L) | Standard Deviation 42.67 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 3 | -1.49 Giga cells per litre (GI/L) | Standard Deviation 1.624 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 5 | -0.17 Giga cells per litre (GI/L) | Standard Deviation 1.618 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 8 | 0.79 Giga cells per litre (GI/L) | Standard Deviation 2.309 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 28/withdrawal | 0.51 Giga cells per litre (GI/L) | Standard Deviation 2.25 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 8 | -0.108 Giga cells per litre (GI/L) | Standard Deviation 0.2043 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 28/withdrawal | -0.016 Giga cells per litre (GI/L) | Standard Deviation 0.2232 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 5 | -0.677 Giga cells per litre (GI/L) | Standard Deviation 1.6269 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 8 | -0.137 Giga cells per litre (GI/L) | Standard Deviation 2.4279 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils:Day 28/withdrawal | -0.381 Giga cells per litre (GI/L) | Standard Deviation 2.192 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 3 | -3.0 Giga cells per litre (GI/L) | Standard Deviation 16.08 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 5 | -0.118 Giga cells per litre (GI/L) | Standard Deviation 0.2104 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 8 | 1.766 Giga cells per litre (GI/L) | Standard Deviation 2.4391 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 28/withdrawal | 1.76 Giga cells per litre (GI/L) | Standard Deviation 1.696 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 3 | -0.070 Giga cells per litre (GI/L) | Standard Deviation 0.1562 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 8 | 0.008 Giga cells per litre (GI/L) | Standard Deviation 0.0311 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 8 | 0.024 Giga cells per litre (GI/L) | Standard Deviation 0.173 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 28/withdrawal | 0.788 Giga cells per litre (GI/L) | Standard Deviation 0.4467 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 8 | 0.722 Giga cells per litre (GI/L) | Standard Deviation 0.5434 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 5 | -0.002 Giga cells per litre (GI/L) | Standard Deviation 0.011 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Monocytes: Day 28/withdrawal | 0.064 Giga cells per litre (GI/L) | Standard Deviation 0.1343 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 5 | 0.576 Giga cells per litre (GI/L) | Standard Deviation 0.3765 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Lymphocytes: Day 3 | 0.432 Giga cells per litre (GI/L) | Standard Deviation 0.5124 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 28/withdrawal | -0.018 Giga cells per litre (GI/L) | Standard Deviation 0.0487 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 3 | -0.416 Giga cells per litre (GI/L) | Standard Deviation 1.0604 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 8 | -0.000 Giga cells per litre (GI/L) | Standard Deviation 0.0959 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 5 | 0.136 Giga cells per litre (GI/L) | Standard Deviation 0.3057 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 3 | -0.008 Giga cells per litre (GI/L) | Standard Deviation 0.013 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils: Day 5 | -0.424 Giga cells per litre (GI/L) | Standard Deviation 0.7956 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Eosinophils: Day 3 | -0.012 Giga cells per litre (GI/L) | Standard Deviation 0.0661 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 3 | -0.06 Giga cells per litre (GI/L) | Standard Deviation 0.691 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 28/withdrawal | 44.2 Giga cells per litre (GI/L) | Standard Deviation 8.76 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Basophils: Day 28/withdrawal | 0.010 Giga cells per litre (GI/L) | Standard Deviation 0.0332 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 5 | 0.18 Giga cells per litre (GI/L) | Standard Deviation 1.221 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 8 | 66.2 Giga cells per litre (GI/L) | Standard Deviation 22.2 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Platelet count: Day 5 | 10.4 Giga cells per litre (GI/L) | Standard Deviation 17.78 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | Total neutrophils:Day 28/withdrawal | 0.970 Giga cells per litre (GI/L) | Standard Deviation 1.8349 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count | WBC count: Day 8 | 2.52 Giga cells per litre (GI/L) | Standard Deviation 2.797 |
Primary
Change From Baseline in Hematology Parameters- Hematocrit
Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 5 | -0.0056 Fraction | Standard Deviation 0.01917 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 3 | -0.0051 Fraction | Standard Deviation 0.0194 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 28/withdrawal | -0.0224 Fraction | Standard Deviation 0.02773 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 8 | -0.0173 Fraction | Standard Deviation 0.01958 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hematocrit | Day 3 | 0.0050 Fraction | Standard Deviation 0.01917 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hematocrit | Day 5 | -0.0029 Fraction | Standard Deviation 0.01734 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hematocrit | Day 8 | -0.0063 Fraction | Standard Deviation 0.01612 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hematocrit | Day 28/withdrawal | -0.0171 Fraction | Standard Deviation 0.01933 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 3 | -0.0126 Fraction | Standard Deviation 0.0231 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 8 | -0.0176 Fraction | Standard Deviation 0.03636 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 5 | -0.0182 Fraction | Standard Deviation 0.0347 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 28/withdrawal | -0.0331 Fraction | Standard Deviation 0.02586 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 5 | -0.0250 Fraction | Standard Deviation 0.03033 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 8 | -0.0244 Fraction | Standard Deviation 0.0414 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 28/withdrawal | -0.0136 Fraction | Standard Deviation 0.03978 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hematocrit | Day 3 | -0.0294 Fraction | Standard Deviation 0.03218 |
Primary
Change From Baseline in Hematology Parameters- Hemoglobin
Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 3 | 0.0 Grams per Litre (G/L) | Standard Deviation 6.08 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 5 | -1.3 Grams per Litre (G/L) | Standard Deviation 6.37 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 8 | -5.2 Grams per Litre (G/L) | Standard Deviation 6.27 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 28/withdrawal | -5.9 Grams per Litre (G/L) | Standard Deviation 9.61 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hemoglobin | Day 5 | 0.4 Grams per Litre (G/L) | Standard Deviation 4.96 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hemoglobin | Day 8 | -0.6 Grams per Litre (G/L) | Standard Deviation 4.65 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hemoglobin | Day 28/withdrawal | -5.1 Grams per Litre (G/L) | Standard Deviation 4.49 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Hemoglobin | Day 3 | 2.2 Grams per Litre (G/L) | Standard Deviation 5.78 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 8 | -6.1 Grams per Litre (G/L) | Standard Deviation 11.65 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 5 | -5.9 Grams per Litre (G/L) | Standard Deviation 10.87 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 28/withdrawal | -10.1 Grams per Litre (G/L) | Standard Deviation 7.83 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 3 | -4.4 Grams per Litre (G/L) | Standard Deviation 6.87 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 28/withdrawal | -4.4 Grams per Litre (G/L) | Standard Deviation 12.14 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 5 | -7.4 Grams per Litre (G/L) | Standard Deviation 11.28 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 3 | -8.8 Grams per Litre (G/L) | Standard Deviation 9.78 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Hemoglobin | Day 8 | -7.0 Grams per Litre (G/L) | Standard Deviation 13.77 |
Primary
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 3 | 0.03 Picogram (PG) | Standard Deviation 0.334 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 5 | -0.11 Picogram (PG) | Standard Deviation 0.407 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 8 | -0.16 Picogram (PG) | Standard Deviation 0.363 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 28/withdrawal | 0.12 Picogram (PG) | Standard Deviation 0.638 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 5 | -0.19 Picogram (PG) | Standard Deviation 0.121 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 8 | -0.13 Picogram (PG) | Standard Deviation 0.198 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 28/withdrawal | -0.00 Picogram (PG) | Standard Deviation 0.231 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 3 | -0.23 Picogram (PG) | Standard Deviation 0.242 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 8 | -0.24 Picogram (PG) | Standard Deviation 0.477 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 5 | -0.14 Picogram (PG) | Standard Deviation 0.609 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 28/withdrawal | 0.18 Picogram (PG) | Standard Deviation 0.479 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 3 | -0.21 Picogram (PG) | Standard Deviation 0.218 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 28/withdrawal | 0.20 Picogram (PG) | Standard Deviation 0.381 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 5 | 0.02 Picogram (PG) | Standard Deviation 0.455 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 3 | 0.06 Picogram (PG) | Standard Deviation 0.329 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Day 8 | 0.08 Picogram (PG) | Standard Deviation 0.277 |
Primary
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 3 | -0.9 Femtoliters (FL) | Standard Deviation 1.38 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 5 | -0.7 Femtoliters (FL) | Standard Deviation 1.2 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 8 | -0.6 Femtoliters (FL) | Standard Deviation 1.55 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 28/withdrawal | -0.4 Femtoliters (FL) | Standard Deviation 2.06 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 5 | -1.3 Femtoliters (FL) | Standard Deviation 1.5 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 8 | -1.1 Femtoliters (FL) | Standard Deviation 1.07 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 28/withdrawal | -0.3 Femtoliters (FL) | Standard Deviation 2.06 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 3 | -0.8 Femtoliters (FL) | Standard Deviation 1.17 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 8 | -0.5 Femtoliters (FL) | Standard Deviation 1.02 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 5 | -0.4 Femtoliters (FL) | Standard Deviation 0.85 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 28/withdrawal | 0.1 Femtoliters (FL) | Standard Deviation 1.04 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 3 | -0.4 Femtoliters (FL) | Standard Deviation 1.7 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 28/withdrawal | 0.6 Femtoliters (FL) | Standard Deviation 0.55 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 5 | -0.2 Femtoliters (FL) | Standard Deviation 0.84 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 3 | -0.2 Femtoliters (FL) | Standard Deviation 0.84 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Day 8 | -0.4 Femtoliters (FL) | Standard Deviation 1.14 |
Primary
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count
Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 3 | -0.00989 Trillion cells per Liter (TI/L) | Standard Deviation 0.032767 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 28/withdrawal | 0.00071 Trillion cells per Liter (TI/L) | Standard Deviation 0.020099 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 8 | -0.13 Trillion cells per Liter (TI/L) | Standard Deviation 0.194 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 5 | -0.01793 Trillion cells per Liter (TI/L) | Standard Deviation 0.02369 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 3 | -0.01 Trillion cells per Liter (TI/L) | Standard Deviation 0.209 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 5 | -0.01 Trillion cells per Liter (TI/L) | Standard Deviation 0.203 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 28/withdrawal | -0.22 Trillion cells per Liter (TI/L) | Standard Deviation 0.272 |
| Danirixin (DNX) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 8 | -0.00158 Trillion cells per Liter (TI/L) | Standard Deviation 0.038763 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 28/withdrawal | -0.16 Trillion cells per Liter (TI/L) | Standard Deviation 0.113 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 28/withdrawal | 0.02313 Trillion cells per Liter (TI/L) | Standard Deviation 0.018277 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 5 | -0.00314 Trillion cells per Liter (TI/L) | Standard Deviation 0.025877 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 5 | 0.06 Trillion cells per Liter (TI/L) | Standard Deviation 0.19 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 3 | 0.13 Trillion cells per Liter (TI/L) | Standard Deviation 0.197 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 8 | 0.01 Trillion cells per Liter (TI/L) | Standard Deviation 0.146 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 8 | -0.00546 Trillion cells per Liter (TI/L) | Standard Deviation 0.022484 |
| Placebo (PBO) | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 3 | -0.00392 Trillion cells per Liter (TI/L) | Standard Deviation 0.018792 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 28/withdrawal | -0.38 Trillion cells per Liter (TI/L) | Standard Deviation 0.283 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 5 | -0.02635 Trillion cells per Liter (TI/L) | Standard Deviation 0.024815 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 3 | -0.11 Trillion cells per Liter (TI/L) | Standard Deviation 0.235 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 5 | -0.19 Trillion cells per Liter (TI/L) | Standard Deviation 0.39 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 8 | -0.17 Trillion cells per Liter (TI/L) | Standard Deviation 0.389 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 3 | -0.01735 Trillion cells per Liter (TI/L) | Standard Deviation 0.025837 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 8 | -0.01032 Trillion cells per Liter (TI/L) | Standard Deviation 0.032152 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 28/withdrawal | -0.00477 Trillion cells per Liter (TI/L) | Standard Deviation 0.030198 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 28/withdrawal | -0.20 Trillion cells per Liter (TI/L) | Standard Deviation 0.464 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 8 | -0.28 Trillion cells per Liter (TI/L) | Standard Deviation 0.476 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 28/withdrawal | 0.01528 Trillion cells per Liter (TI/L) | Standard Deviation 0.018 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 8 | 0.01020 Trillion cells per Liter (TI/L) | Standard Deviation 0.00626 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 5 | -0.28 Trillion cells per Liter (TI/L) | Standard Deviation 0.363 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | RBC: Day 3 | -0.32 Trillion cells per Liter (TI/L) | Standard Deviation 0.37 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 3 | -0.01694 Trillion cells per Liter (TI/L) | Standard Deviation 0.029436 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count | Reticulocytes: Day 5 | -0.01406 Trillion cells per Liter (TI/L) | Standard Deviation 0.024957 |
Primary
Change From Baseline in Urinalysis Parameters- Urine pH
Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1), Day 5 and Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Urinalysis Parameters- Urine pH | Day 5 | 0.00 Points on a scale | Standard Deviation 0.784 |
| Danirixin (DNX) 75 mg | Change From Baseline in Urinalysis Parameters- Urine pH | Day 28/withdrawal | 0.27 Points on a scale | Standard Deviation 0.633 |
| Placebo (PBO) | Change From Baseline in Urinalysis Parameters- Urine pH | Day 28/withdrawal | 0.14 Points on a scale | Standard Deviation 0.852 |
| Placebo (PBO) | Change From Baseline in Urinalysis Parameters- Urine pH | Day 5 | 0.21 Points on a scale | Standard Deviation 0.951 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine pH | Day 5 | 0.20 Points on a scale | Standard Deviation 0.592 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine pH | Day 28/withdrawal | 0.07 Points on a scale | Standard Deviation 0.938 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine pH | Day 5 | 0.40 Points on a scale | Standard Deviation 0.652 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine pH | Day 28/withdrawal | 0.70 Points on a scale | Standard Deviation 0.57 |
Primary
Change From Baseline in Urinalysis Parameters- Urine Specific Gravity
Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1), Day 5 and Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 5 | -0.0001 Ratio | Standard Deviation 0.00469 |
| Danirixin (DNX) 75 mg | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 28/withdrawal | -0.0045 Ratio | Standard Deviation 0.00702 |
| Placebo (PBO) | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 28/withdrawal | 0.0013 Ratio | Standard Deviation 0.00929 |
| Placebo (PBO) | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 5 | -0.0004 Ratio | Standard Deviation 0.00675 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 5 | -0.0038 Ratio | Standard Deviation 0.00731 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 28/withdrawal | -0.0021 Ratio | Standard Deviation 0.00855 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 5 | -0.0076 Ratio | Standard Deviation 0.00385 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Urinalysis Parameters- Urine Specific Gravity | Day 28/withdrawal | -0.0050 Ratio | Standard Deviation 0.00656 |
Primary
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 3 | -2.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.07 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 5 | 0.3 Millimeters of Mercury (mmHg) | Standard Deviation 6.76 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 8 | -4.4 Millimeters of Mercury (mmHg) | Standard Deviation 7.13 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 14 | -4.5 Millimeters of Mercury (mmHg) | Standard Deviation 7.43 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 28/withdrawal | -4.4 Millimeters of Mercury (mmHg) | Standard Deviation 10.37 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 3 | -5.73 Millimeters of Mercury (mmHg) | Standard Deviation 13.599 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 5 | -3.00 Millimeters of Mercury (mmHg) | Standard Deviation 11.802 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 8 | -5.86 Millimeters of Mercury (mmHg) | Standard Deviation 19.907 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 14 | -6.20 Millimeters of Mercury (mmHg) | Standard Deviation 12.26 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 28/withdrawal | -3.36 Millimeters of Mercury (mmHg) | Standard Deviation 16.284 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 8 | -4.6 Millimeters of Mercury (mmHg) | Standard Deviation 10.36 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 14 | -4.57 Millimeters of Mercury (mmHg) | Standard Deviation 10.163 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 14 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 10.63 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 28/withdrawal | -0.6 Millimeters of Mercury (mmHg) | Standard Deviation 13.82 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 3 | -5.29 Millimeters of Mercury (mmHg) | Standard Deviation 8.597 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 5 | -0.71 Millimeters of Mercury (mmHg) | Standard Deviation 4.923 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 28/withdrawal | -0.43 Millimeters of Mercury (mmHg) | Standard Deviation 7.115 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 8 | -9.29 Millimeters of Mercury (mmHg) | Standard Deviation 13.889 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 3 | -0.7 Millimeters of Mercury (mmHg) | Standard Deviation 7.97 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 5 | -1.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.76 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 8 | -2.60 Millimeters of Mercury (mmHg) | Standard Deviation 13.741 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 5 | -1.93 Millimeters of Mercury (mmHg) | Standard Deviation 11.279 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 28/withdrawal | -0.80 Millimeters of Mercury (mmHg) | Standard Deviation 6.982 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 3 | -1.1 Millimeters of Mercury (mmHg) | Standard Deviation 9.18 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 14 | 0.8 Millimeters of Mercury (mmHg) | Standard Deviation 9.66 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 3 | -2.87 Millimeters of Mercury (mmHg) | Standard Deviation 6.802 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 14 | -1.20 Millimeters of Mercury (mmHg) | Standard Deviation 12.667 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 5 | -2.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.53 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 28/withdrawal | -1.1 Millimeters of Mercury (mmHg) | Standard Deviation 8.18 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 8 | -2.3 Millimeters of Mercury (mmHg) | Standard Deviation 7.96 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 28/withdrawal | -3.5 Millimeters of Mercury (mmHg) | Standard Deviation 6.57 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 8 | 0.60 Millimeters of Mercury (mmHg) | Standard Deviation 10.164 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 3 | -5.00 Millimeters of Mercury (mmHg) | Standard Deviation 5.568 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 28/withdrawal | -2.83 Millimeters of Mercury (mmHg) | Standard Deviation 7.278 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 5 | -3.00 Millimeters of Mercury (mmHg) | Standard Deviation 8.456 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 5 | -5.2 Millimeters of Mercury (mmHg) | Standard Deviation 6.98 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 8 | -0.8 Millimeters of Mercury (mmHg) | Standard Deviation 5.07 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 14 | -7.8 Millimeters of Mercury (mmHg) | Standard Deviation 4.87 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP: Day 3 | -4.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.9 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP: Day 14 | -3.80 Millimeters of Mercury (mmHg) | Standard Deviation 7.259 |
Primary
Change From Baseline in Vital Signs- Heart Rate (HR)
Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 5 | -2.60 Beats per minute | Standard Deviation 7.385 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 3 | 3.93 Beats per minute | Standard Deviation 10.375 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 28/withdrawal | -6.57 Beats per minute | Standard Deviation 11.043 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 8 | -2.79 Beats per minute | Standard Deviation 10.297 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 14 | 0.80 Beats per minute | Standard Deviation 13.165 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 8 | -12.29 Beats per minute | Standard Deviation 21.422 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 14 | -13.43 Beats per minute | Standard Deviation 14.444 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 3 | -8.00 Beats per minute | Standard Deviation 14.855 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 5 | -10.29 Beats per minute | Standard Deviation 21.109 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 28/withdrawal | -17.14 Beats per minute | Standard Deviation 19.912 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 14 | -8.73 Beats per minute | Standard Deviation 14.553 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 28/withdrawal | -11.80 Beats per minute | Standard Deviation 15.799 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 3 | -8.87 Beats per minute | Standard Deviation 11.637 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 5 | -9.60 Beats per minute | Standard Deviation 14.161 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 8 | -10.87 Beats per minute | Standard Deviation 14.589 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 28/withdrawal | 0.17 Beats per minute | Standard Deviation 12.952 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 5 | -6.80 Beats per minute | Standard Deviation 12.637 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 8 | -0.80 Beats per minute | Standard Deviation 17.541 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 14 | -4.20 Beats per minute | Standard Deviation 17.584 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Heart Rate (HR) | Heart rate: Day 3 | -1.20 Beats per minute | Standard Deviation 16.976 |
Primary
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)
Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 14 | -0.7 Percentage (%) | Standard Deviation 1.71 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 5 | -0.7 Percentage (%) | Standard Deviation 1.35 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 28/withdrawal | -1.1 Percentage (%) | Standard Deviation 1.83 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 8 | -0.8 Percentage (%) | Standard Deviation 1.31 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 3 | -1.7 Percentage (%) | Standard Deviation 3.97 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 8 | 0.4 Percentage (%) | Standard Deviation 1.62 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 14 | 0.9 Percentage (%) | Standard Deviation 3.13 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 28/withdrawal | 1.1 Percentage (%) | Standard Deviation 1.86 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 5 | -0.4 Percentage (%) | Standard Deviation 3.1 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 3 | 1.1 Percentage (%) | Standard Deviation 1.68 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 8 | -0.1 Percentage (%) | Standard Deviation 2.09 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 3 | 0.1 Percentage (%) | Standard Deviation 1.6 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 5 | 0.4 Percentage (%) | Standard Deviation 1.76 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 14 | 0.0 Percentage (%) | Standard Deviation 1.77 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 28/withdrawal | 0.2 Percentage (%) | Standard Deviation 1.42 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 14 | 0.8 Percentage (%) | Standard Deviation 2.39 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 5 | 1.0 Percentage (%) | Standard Deviation 2 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 3 | 0.4 Percentage (%) | Standard Deviation 2.61 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 8 | 0.8 Percentage (%) | Standard Deviation 3.7 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB) | POB: Day 28/withdrawal | 1.5 Percentage (%) | Standard Deviation 2.88 |
Primary
Change From Baseline in Vital Signs- Respiration Rate (RR)
Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 14 | -0.7 Breaths per minute | Standard Deviation 2.66 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 5 | -0.5 Breaths per minute | Standard Deviation 2.1 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 28/withdrawal | -0.4 Breaths per minute | Standard Deviation 2.02 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 8 | -0.3 Breaths per minute | Standard Deviation 2.46 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 3 | -0.1 Breaths per minute | Standard Deviation 2.03 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 14 | 0.6 Breaths per minute | Standard Deviation 2.23 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 8 | 0.7 Breaths per minute | Standard Deviation 2.21 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 28/withdrawal | 0.4 Breaths per minute | Standard Deviation 3.46 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 5 | 0.0 Breaths per minute | Standard Deviation 1.63 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 3 | 0.0 Breaths per minute | Standard Deviation 2 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 3 | -0.5 Breaths per minute | Standard Deviation 2.23 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 5 | -0.7 Breaths per minute | Standard Deviation 2.58 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 8 | -0.6 Breaths per minute | Standard Deviation 2.38 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 14 | -0.3 Breaths per minute | Standard Deviation 2.77 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 28/withdrawal | -0.3 Breaths per minute | Standard Deviation 2.97 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 3 | 1.4 Breaths per minute | Standard Deviation 1.95 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 28/withdrawal | 0.8 Breaths per minute | Standard Deviation 2.23 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 8 | 0.6 Breaths per minute | Standard Deviation 1.34 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 5 | 1.2 Breaths per minute | Standard Deviation 1.1 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Respiration Rate (RR) | RR: Day 14 | 0.8 Breaths per minute | Standard Deviation 1.1 |
Primary
Change From Baseline in Vital Signs- Temperature
Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 28/withdrawal | -0.71 Centigrade | Standard Deviation 1.24 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 5 | -0.75 Centigrade | Standard Deviation 1.278 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 3 | -0.20 Centigrade | Standard Deviation 1.342 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 8 | -0.46 Centigrade | Standard Deviation 0.818 |
| Danirixin (DNX) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 14 | -0.73 Centigrade | Standard Deviation 1.177 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Temperature | Temperature: Day 5 | -1.34 Centigrade | Standard Deviation 0.978 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Temperature | Temperature: Day 8 | -1.50 Centigrade | Standard Deviation 1.127 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Temperature | Temperature: Day 28/withdrawal | -1.39 Centigrade | Standard Deviation 0.958 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Temperature | Temperature: Day 3 | -1.11 Centigrade | Standard Deviation 0.749 |
| Placebo (PBO) | Change From Baseline in Vital Signs- Temperature | Temperature: Day 14 | -1.59 Centigrade | Standard Deviation 1.051 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 3 | -0.57 Centigrade | Standard Deviation 0.884 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 5 | -0.76 Centigrade | Standard Deviation 0.766 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 14 | -0.83 Centigrade | Standard Deviation 0.97 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 28/withdrawal | -0.71 Centigrade | Standard Deviation 0.905 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 8 | -0.83 Centigrade | Standard Deviation 0.786 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 5 | -0.14 Centigrade | Standard Deviation 0.422 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 3 | -0.08 Centigrade | Standard Deviation 0.239 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 8 | -0.16 Centigrade | Standard Deviation 0.537 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 14 | -0.28 Centigrade | Standard Deviation 0.409 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Vital Signs- Temperature | Temperature: Day 28/withdrawal | -0.22 Centigrade | Standard Deviation 0.454 |
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time frame: Up to Day 28/withdrawal
Population: Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 3 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 1 Participants |
| Placebo (PBO) | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| Placebo (PBO) | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 4 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 7 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
Primary
Number of Participants With Disease Related Events (DREs) of Interest
Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.
Time frame: Up to Day 28/withdrawal
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With Disease Related Events (DREs) of Interest | 2 Participants |
| Placebo (PBO) | Number of Participants With Disease Related Events (DREs) of Interest | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Disease Related Events (DREs) of Interest | 1 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Disease Related Events (DREs) of Interest | 0 Participants |
Primary
Number of Participants With DRE of Interest-associated Antibiotic Use
Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.
Time frame: Up to Day 28/withdrawal
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With DRE of Interest-associated Antibiotic Use | 0 Participants |
| Placebo (PBO) | Number of Participants With DRE of Interest-associated Antibiotic Use | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With DRE of Interest-associated Antibiotic Use | 1 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With DRE of Interest-associated Antibiotic Use | 0 Participants |
Primary
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Time frame: Up to Day 28/withdrawal
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 3+ OR 1 G/DL (%) | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 1+ OR 1/4 G/DL (%) | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 4+ | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 2+ OR 1/2 G/DL (%) | 1 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 3+ OR 1 G/DL (%) | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 2+ OR 1/2 G/DL (%) | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 4+ | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 1+ OR 1/4 G/DL (%) | 1 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 4+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 1+ OR 1/4 G/DL (%) | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 2+ OR 1/2 G/DL (%) | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick) | 3+ OR 1 G/DL (%) | 1 Participants |
Primary
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Time frame: Up to Day 28/withdrawal
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 1+ | 2 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 2+ | 1 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 3+ | 1 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 4+ | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 4+ | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 2+ | 1 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 1+ | 1 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 3+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 1+ | 1 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 2+ | 1 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 3+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick) | 4+ | 2 Participants |
Primary
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Time frame: Up to Day 28/withdrawal
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 1+ | 3 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 2+ | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 3+ | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 4+ | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 2+ | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 3+ | 1 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 4+ | 0 Participants |
| Placebo (PBO) | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 1+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 3+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 2+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 4+ | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 1+ | 3 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 4+ | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 2+ | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 1+ | 1 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick) | 3+ | 0 Participants |
Secondary
Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Population: IPP population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -1.912 Log viral particles/mL | Standard Deviation 1.2895 |
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -3.764 Log viral particles/mL | Standard Deviation 1.8831 |
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -0.897 Log viral particles/mL | Standard Deviation 1.139 |
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -4.024 Log viral particles/mL | Standard Deviation 1.0387 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -2.812 Log viral particles/mL | Standard Deviation 1.8841 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -4.063 Log viral particles/mL | Standard Deviation 1.412 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -4.992 Log viral particles/mL | Standard Deviation 1.1296 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -1.415 Log viral particles/mL | Standard Deviation 1.5986 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -4.518 Log viral particles/mL | Standard Deviation 1.2408 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -2.962 Log viral particles/mL | Standard Deviation 1.8515 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -1.620 Log viral particles/mL | Standard Deviation 1.3461 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -3.862 Log viral particles/mL | Standard Deviation 1.3284 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -2.644 Log viral particles/mL | Standard Deviation 0.5206 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -4.250 Log viral particles/mL | Standard Deviation 1.7995 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -4.250 Log viral particles/mL | Standard Deviation 1.7995 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -1.904 Log viral particles/mL | Standard Deviation 1.6289 |
Secondary
Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time frame: Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Population: IPP population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -1.810 Log median tissue culture infective dose | Standard Deviation 1.4374 |
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -2.534 Log median tissue culture infective dose | Standard Deviation 1.4499 |
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -2.885 Log median tissue culture infective dose | Standard Deviation 1.1877 |
| Danirixin (DNX) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -2.564 Log median tissue culture infective dose | Standard Deviation 1.4694 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -2.172 Log median tissue culture infective dose | Standard Deviation 1.9242 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -2.843 Log median tissue culture infective dose | Standard Deviation 2.2061 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -2.260 Log median tissue culture infective dose | Standard Deviation 1.8792 |
| Placebo (PBO) | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -0.753 Log median tissue culture infective dose | Standard Deviation 1.8251 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -2.698 Log median tissue culture infective dose | Standard Deviation 1.4621 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -2.467 Log median tissue culture infective dose | Standard Deviation 1.8842 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -2.614 Log median tissue culture infective dose | Standard Deviation 1.5899 |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -1.943 Log median tissue culture infective dose | Standard Deviation 2.0079 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 14 | -3.108 Log median tissue culture infective dose | Standard Deviation 2.0998 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 5 | -3.108 Log median tissue culture infective dose | Standard Deviation 2.0998 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 3 | -2.304 Log median tissue culture infective dose | Standard Deviation 1.9351 |
| Oseltamivir (OSV) 75 mg | Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14 | Day 8 | -3.108 Log median tissue culture infective dose | Standard Deviation 2.0998 |
Secondary
Number of Afebrile Participants Over Time Post Initiation of Treatment
Afebrile participants were defined as participants with oral temperature \<=37.2 degree Celsius, \<=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature \<=37.2 degree Celsius or \<=99 degree Fahrenheit for 24 hours.
Time frame: Up to Day 28/withdrawal
Population: IPP population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 336 hours | 5 Participants |
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 192 hours | 4 Participants |
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 0 hour | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 24 hours | 1 Participants |
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 672 hours | 5 Participants |
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 72 hours | 2 Participants |
| Danirixin (DNX) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 120 hours | 4 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 0 hour | 0 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 120 hours | 4 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 192 hours | 6 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 72 hours | 2 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 672 hours | 6 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 336 hours | 6 Participants |
| Placebo (PBO) | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 24 hours | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 336 hours | 11 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 672 hours | 11 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 24 hours | 2 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 0 hour | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 72 hours | 8 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 120 hours | 10 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 192 hours | 11 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 72 hours | 2 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 0 hour | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 24 hours | 1 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 120 hours | 3 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 192 hours | 3 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 336 hours | 3 Participants |
| Oseltamivir (OSV) 75 mg | Number of Afebrile Participants Over Time Post Initiation of Treatment | At 672 hours | 3 Participants |
Secondary
Number of Hospital Admissions Due to Influenza Infection
Number of participants admitted in hospital due to influenza infection was recorded.
Time frame: Up to Day 28/withdrawal
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Danirixin (DNX) 75 mg | Number of Hospital Admissions Due to Influenza Infection | 0 Participants |
| Placebo (PBO) | Number of Hospital Admissions Due to Influenza Infection | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Hospital Admissions Due to Influenza Infection | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Hospital Admissions Due to Influenza Infection | 0 Participants |
Secondary
Number of Participants Who Used Relief Medication
Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.
Time frame: Up to Day 28/withdrawal
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants Who Used Relief Medication | Paracetamol use | 12 Participants |
| Danirixin (DNX) 75 mg | Number of Participants Who Used Relief Medication | Dextromethorphan use | 12 Participants |
| Placebo (PBO) | Number of Participants Who Used Relief Medication | Dextromethorphan use | 5 Participants |
| Placebo (PBO) | Number of Participants Who Used Relief Medication | Paracetamol use | 7 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants Who Used Relief Medication | Paracetamol use | 15 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants Who Used Relief Medication | Dextromethorphan use | 13 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants Who Used Relief Medication | Paracetamol use | 7 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants Who Used Relief Medication | Dextromethorphan use | 7 Participants |
Secondary
Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
Time frame: Up to Day 14
Population: IPP Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 5 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 3 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 0 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 0 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 0 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 0 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 4 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 1 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 11 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 3 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 6 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 1 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 5 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 0 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 5 Participants |
Secondary
Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
Time frame: Up to Day 14
Population: IPP Population. Only those participants (number with nasopharyngeal samples) available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 8 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 5 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 9 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 7 Participants |
| Danirixin (DNX) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 1 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 3 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 6 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 5 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 2 Participants |
| Placebo (PBO) | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 10 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 0 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 6 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 12 Participants |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 12 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 8 | 5 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 3 | 3 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 1 | 2 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 5 | 5 Participants |
| Oseltamivir (OSV) 75 mg | Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 | Day 14 | 5 Participants |
Secondary
Time to Resolution of Fever Over Time Post Initiation of Treatment
Time to resolution of fever was defined as the time when oral temperature was \<= 37.2 degree Celsius (\<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature \<=37.2 degree Celsius or \<=99 degree Fahrenheit for 24 hours.
Time frame: Up to Day 28/withdrawal
Population: Influenza positive population (IPP) comprised of all randomized participants who received at least one dose of IP with proven influenza infection (positive rapid antigen test and positive influenza by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) or culture test at any time point). Participants with fever are analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Danirixin (DNX) 75 mg | Time to Resolution of Fever Over Time Post Initiation of Treatment | 119.833 Hours |
| Placebo (PBO) | Time to Resolution of Fever Over Time Post Initiation of Treatment | 98.092 Hours |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Time to Resolution of Fever Over Time Post Initiation of Treatment | 54.425 Hours |
| Oseltamivir (OSV) 75 mg | Time to Resolution of Fever Over Time Post Initiation of Treatment | 76.167 Hours |
Secondary
Total Dose of Relief Medication
Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.
Time frame: Up to Day 28/withdrawal
Population: Safety population. Only those participants using relief medication were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Danirixin (DNX) 75 mg | Total Dose of Relief Medication | Paracetamol total dose | 5000.00 Milligrams |
| Danirixin (DNX) 75 mg | Total Dose of Relief Medication | Dextromethorphan total dose | 150.00 Milligrams |
| Placebo (PBO) | Total Dose of Relief Medication | Dextromethorphan total dose | 390.00 Milligrams |
| Placebo (PBO) | Total Dose of Relief Medication | Paracetamol total dose | 9000.00 Milligrams |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Total Dose of Relief Medication | Paracetamol total dose | 5500.00 Milligrams |
| Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg | Total Dose of Relief Medication | Dextromethorphan total dose | 120.00 Milligrams |
| Oseltamivir (OSV) 75 mg | Total Dose of Relief Medication | Paracetamol total dose | 3000.00 Milligrams |
| Oseltamivir (OSV) 75 mg | Total Dose of Relief Medication | Dextromethorphan total dose | 60.00 Milligrams |