Duchenne Muscular Dystrophy
Conditions
Keywords
gene therapy, mini-dystrophin, AAV, fordadistrogene movaparvovec
Brief summary
This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with Duchenne muscular dystrophy (DMD). Other objectives include measurement of dystrophin expression and distribution, and assessments of muscle strength, quality, and function. A total of approximately 22 subjects will receive PF-06939926, and these will include both ambulatory and non-ambulatory subjects. Up to 13 subjects may be included in a cohort that includes the concomitant medication, sirolimus. In order to mitigate unanticipated risks to subject safety, enrollment will be staggered within and between two planned dose-levels and will include a formal review by an external data monitoring committee (E-DMC) prior to dose progression.
Interventions
GENETICPF-06939926
Recombinant adeno-associated virus, serotype 9 (AAV9) carrying a truncated human dystrophin gene (mini-dystrophin) under the control of a muscle-specific promoter. Subjects will receive a single intravenous infusion of one of 2 dose levels.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age as follows, based on ambulatory status: * FOR AMBULATORY PARTICIPANTS, defined as the ability to walk at least 10 meters unassisted: Between 4 and 12 years, inclusive, * FOR NON-AMBULATORY PARTICIPANTS, defined as the inability to walk at least 10 meters unassisted: No age restrictions so long as loss of ambulation occurs prior to the subject's 17th birthday; * Diagnosis of Duchenne muscular dystrophy confirmed by medical history and genetic testing; * Receipt of glucocorticoids for 6 months and a stable daily dose for at least 3 months prior to study entry; * Ability to tolerate magnetic resonance imaging (MRI) without sedation and with no contraindications to these procedures; * Ability to tolerate muscle biopsies under anesthesia with no contraindications to these procedures; * Body weights as follows, based on ambulatory status: * FOR AMBULATORY PARTICIPANTS: Between 15 kg and 50 kg, * FOR NON-AMBULATORY PARTICIPANTS: Less than 75 kg, but which may be managed or adjusted to a lower limit, especially to ensure participant safety; * Functional performance as follows, based on ambulatory status: * FOR AMBULATORY PARTICIPANTS: Ability to rise from floor within seven (7) seconds, * FOR NON-AMBULATORY PARTICIPANTS: Percent predicted forced vital capacity greater than 40% as part of pulmonary function tests, as well as adequate upper limb function.
Exclusion criteria
* Receipt of live attenuated vaccination within 3 months prior to receiving PF-06939926 or exposure to an influenza (or other inactivated) vaccination or systemic antiviral and/or interferon therapy within 30 days prior to receipt of PF-06939926; * Prior exposure to any gene therapy agent, including exon-skipping agents; * Exposure to other investigational drugs within 30 days or 5 half-lives, whichever is longer; * Neutralizing antibodies (NAb) against adeno-associated virus, serotype 9 (AAV9); * Compromised cardiac function as indicated by left ventricular ejection fraction on cardiac MRI, as follows, based on ambulatory status: * FOR AMBULATORY PARTICIPANTS: Less than 55%, * FOR NON-AMBULATORY PARTICIPANTS: Less than 35%; * Inadequate hepatic or renal function or risk factors for autoimmune disease on screening laboratory assessments. * The following genetic abnormalities in the dystrophin gene as confirmed by the investigator based on the review of the DMD genetic testing: 1. Any mutation (exon deletion, exon duplication, insertion, or point mutation) affecting any exon between exon 9 and exon 13, inclusive; OR 2. A deletion that affects both exon 29 and exon 30. Sirolimus Cohort Inclusion Criteria * \> 8 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a treatment-emergent AE (TEAE). A serious AE (SAE) was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. Severe AE=an event that prevents normal everyday activities. |
| Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. For this outcome measure, TEAEs were reported according to Medical Dictionary for Regulatory Activities (MedDRA) version 25.0 SOC and PT. |
| Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. An SAE was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. Severe AE=an event that prevents normal everyday activities. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-related AEs and SAEs were determined by the investigator. |
| Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. For this outcome measure, TEAEs were reported according to MedDRA version 25.0 SOC and PT. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-related AEs were determined by the investigator. |
| Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. An SAE was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. For this outcome measure, TEAEs were reported according to MedDRA version 25.0 SOC and PT. |
| Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. An SAE was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-related AEs and SAEs were determined by the investigator. For this outcome measure, TEAEs were reported according to MedDRA version 25.0 SOC and PT. |
| Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Baseline up to 1 year post dose of PF-06939926 | Following hematologic parameters were analyzed for laboratory examination: hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell count, total neutrophils, absolute neutrophils (ANC), eosinophils, monocytes, basophils, lymphocytes, red blood cell indices, and haptoglobin. Laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last pre-dose measurement. |
| Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Baseline up to 1 year post dose of PF-06939926 | Following parameters for clinical chemistry were analyzed for laboratory examination: blood urea nitrogen (BUN) and creatinine, glucose, calcium, sodium, potassium, chloride, total CO2 (bicarbonate), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (direct and indirect bilirubin), alkaline phosphatase, uric acid, albumin, total protein, serum phosphorus, cystatin C, creatine kinase, creatine kinase myocardial b fraction (CK-MB), amylase, lipase, gamma-glutamyl transferase (GGT), C-reactive protein (CRP), and cardiac troponin I. Laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last pre-dose measurement. |
| Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Baseline up to 1 year post dose of PF-06939926 | Following parameters for urinalysis were analyzed for laboratory examination: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy. Laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last pre-dose measurement. |
| Change From Baseline on Left Ventricular Ejection Fraction as Measured by Cardiac Magnetic Resonance Imaging (MRI) for 1-Year Follow-Up | Baseline, 1 year post dose of PF-06839926 (Day 360) | Cardiac MRI was performed after thigh and upper limb MRI or on separate days within the required visit window. Change in LVEF is presented as percentages, and was calculated as \[(stroke volume) / (end-diastolic volume)\]\*100%. Baseline is defined as the last pre-dose measurement. Change from baseline on Day 360 (ie, 1 year post dose) was reported for this outcome measure. |
| Number of Participants With Electrocardiograms (ECGs) Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | Triplicate ECG was performed after the participant had rested quietly for at least 10 minutes in a supine position. The pre-defined categorical criteria include PR interval aggregate (msec): value\>=300, baseline\>200 and percent change\>=25%, baseline\<=200 and percent change\>=50%; QRS duration aggregate (msec): value\>=140, percent change\>=50%; QTcF interval aggregate (msec): 450\<=value\<480, 480\<=value\<500, value\>=500, 30\<=change\<60, change\>=60. Only the category(ies) with at least 1 participant meeting the pre-defined criterion is/are reported for this outcome measure. Baseline for ECG was defined as the measurement before the Day 1 study drug administration. |
| Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline, Day 7, Day 14, Day 180, and Day 360 | C-SSRS is a participant rated questionnaire to assess whether participant experienced the following: completed suicide(1), suicide attempt(2)(Yes on actual attempt), preparatory acts toward imminent suicidal behavior(3)(Yes on preparatory acts or behavior), suicidal ideation(4)(Yes on wish to be dead,non-specific active suicidal thoughts,active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(Yes on Has subject engaged in non-suicidal self-injurious behavior). Yes/No responses are mapped to C-CASA categories. C-SSRS was conducted with the participant's care giver/legal guardian on the participant's behalf throughout the study for participants\<=12 years of age at screening. Baseline is defined as the last predose measurement. Number of participants with responses of Yes is reported for this outcome measure. |
| Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Baseline up to 1 year post dose of PF-06939926 | Vital signs consisted of blood pressure, respiratory rate, and heart rate, was obtained with these measurements at the following timepoints: within 30 minutes before and approximately 30 minutes, 1, 2, 4, 8, and 24 hours after the start of the infusion, and on Days 4, 7, 10, 14, 30, 90, 180, and 360. Baseline was defined as the last pre-dose recording. Number of participants who had at least 1 vital sign measurement at the specified timepoints meeting the pre-defined criteria from baseline up to the end of 1-year follow-up is reported for this outcome measure. |
Countries
United States
Participant flow
Recruitment details
The study reached its primary completion date (PCD) on 28 Mar 2022. The data cutoff for PCD was on 30 Sep 2022. As of 30 Sep 2022, a total of 22 participants, including 19 ambulatory participants and 3 non-ambulatory participants, were enrolled and assigned to treatment.
Pre-assignment details
One participant was enrolled but not dosed due to a pause in enrollment. The participant was considered as an early termination due to screening window running out. The participant was subsequently re-screened and assigned to study intervention with another participant ID. Therefore, a total of 22 unique participants were enrolled as of 30 Sep 2022.
Participants by arm
| Arm | Count |
|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort Ambulatory participants received a single intravenous (IV) infusion of PF-06939926 1E+14 vector genomes per kilogram bodyweight (vg/kg) on Day 1, followed by at least 24 hours of in-patient monitoring, a 2-week follow-up visit, 1-year follow-up, and long-term follow-up for 4 years. | 3 |
| PF-06939926: High Dose, Ambulatory Cohort Ambulatory participants received a single IV infusion of PF-06939926 2E+14 vg/kg per transgene (TG)-based titer method or 3E+14 vg/kg per the inverted terminal repeats (ITR)-based titer method on Day 1, followed by at least 24 hours of in-patient monitoring, a 2-week follow-up visit, 1-year follow-up, and long-term follow-up for 4 years. PF-06939926 at 3E+14 vg/kg per the ITR-based titer method is approximately equivalent to 2E+14 vg/kg per the TG-titer method. | 16 |
| PF-06939926: High Dose, Non-Ambulatory Cohort Non-ambulatory participants received a single IV infusion of PF-06939926 2E+14 vg/kg per TG-based titer method or 3E+14 vg/kg per the ITR-based titer method on Day 1, followed by at least 24 hours of in-patient monitoring, a 2-week follow-up visit, 1-year follow-up, and long-term follow-up for 4 years. PF-06939926 at 3E+14 vg/kg per the ITR-based titer method is approximately equivalent to 2E+14 vg/kg per the TG-titer method. | 3 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | PF-06939926: High Dose, Non-Ambulatory Cohort | PF-06939926: High Dose, Ambulatory Cohort | PF-06939926: Low Dose, Ambulatory Cohort |
|---|---|---|---|---|
| Age, Customized 10-<11 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Customized 11-<12 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=12 years | 4 Participants | 3 Participants | 1 Participants | 0 Participants |
| Age, Customized 6-<7 years | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Age, Customized 7-<8 years | 5 Participants | 0 Participants | 4 Participants | 1 Participants |
| Age, Customized 8-<9 years | 5 Participants | 0 Participants | 4 Participants | 1 Participants |
| Age, Customized 9-<10 years | 5 Participants | 0 Participants | 4 Participants | 1 Participants |
| Age, Customized | 8 Years | 14 Years | 8 Years | 8 Years |
| Mutation Type Cryptic Splice Donor Site | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Mutation Type Deletion | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Mutation Type Exon Deletion | 10 Participants | 2 Participants | 7 Participants | 1 Participants |
| Mutation Type Exon Duplication | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Mutation Type Insertion | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Mutation Type Point Mutation | 6 Participants | 1 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 1 Participants | 13 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 3 Participants | 16 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 16 | 1 / 3 |
| other Total, other adverse events | 3 / 3 | 16 / 16 | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 | 3 / 16 | 2 / 3 |
Outcome results
Primary
Change From Baseline on Left Ventricular Ejection Fraction as Measured by Cardiac Magnetic Resonance Imaging (MRI) for 1-Year Follow-Up
Cardiac MRI was performed after thigh and upper limb MRI or on separate days within the required visit window. Change in LVEF is presented as percentages, and was calculated as \[(stroke volume) / (end-diastolic volume)\]\*100%. Baseline is defined as the last pre-dose measurement. Change from baseline on Day 360 (ie, 1 year post dose) was reported for this outcome measure.
Time frame: Baseline, 1 year post dose of PF-06839926 (Day 360)
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population and had reportable data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Change From Baseline on Left Ventricular Ejection Fraction as Measured by Cardiac Magnetic Resonance Imaging (MRI) for 1-Year Follow-Up | -0.7 Percentage | Standard Deviation 3.2 |
| PF-06939926: High Dose, Ambulatory Cohort | Change From Baseline on Left Ventricular Ejection Fraction as Measured by Cardiac Magnetic Resonance Imaging (MRI) for 1-Year Follow-Up | -1.0 Percentage | Standard Deviation 4.3 |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Change From Baseline on Left Ventricular Ejection Fraction as Measured by Cardiac Magnetic Resonance Imaging (MRI) for 1-Year Follow-Up | -3.1 Percentage | Standard Deviation 1.8 |
Primary
Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. An SAE was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. For this outcome measure, TEAEs were reported according to MedDRA version 25.0 SOC and PT.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Urinary tract infection | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Urinary tract infection | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Urinary tract infection | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 1 Participants |
Primary
Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. For this outcome measure, TEAEs were reported according to Medical Dictionary for Regulatory Activities (MedDRA) version 25.0 SOC and PT.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Gastrooesophageal reflux disease | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Ketonuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Hepatic enzyme increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Inguinal hernia | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Arthralgia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Glutamate dehydrogenase increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Nausea | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Glycosuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Amylase increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Toothache | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Chronic kidney disease | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Vomiting | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Skin abrasion | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Pain in extremity | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Post procedural contusion | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Chest pain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: ENDOCRINE DISORDERS, PT: Androgen deficiency | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Ligament sprain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Fatigue | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Joint injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Pyrexia | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Irritability | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Joint dislocation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Haematuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Fall | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, PT: Liver injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Proteinuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Contusion | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Cellulitis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Rhinorrhoea | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Urinary tract infection | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Conjunctivitis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Urticaria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Tooth abscess | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Influenza | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Suicidal ideation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Nasopharyngitis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Molluscum contagiosum | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Ecchymosis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Parainfluenzae virus infection | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Sinusitis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Mood altered | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Anaemia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: ENDOCRINE DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Anxiety | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolysis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Rash | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Affect lability | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain upper | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Abnormal behaviour | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Leukocytosis | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Lymphopenia | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Viral upper respiratory tract infection | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Migraine | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Infusion site reaction | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Lethargy | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Oropharyngeal pain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Headache | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, PT: Hypertension | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Dizziness | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiomyopathy | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Procedural pain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Osteopenia | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: EYE DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Myalgia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: EYE DISORDERS, PT: Lacrimation increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Epistaxis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Back pain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, Total | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Cough | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Complement factor C4 decreased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Hyperuricaemia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain lower | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Cystatin C increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Decreased appetite | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Constipation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Mass | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Troponin increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Diarrhoea | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Lipase increased | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Vomiting | 13 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: ENDOCRINE DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: ENDOCRINE DISORDERS, PT: Androgen deficiency | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Infusion site reaction | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Mass | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Tooth abscess | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Urinary tract infection | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Contusion | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Ligament sprain | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Procedural pain | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Lethargy | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, Total | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 9 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Anaemia | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolysis | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Leukocytosis | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Lymphopenia | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 9 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiomyopathy | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: EYE DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: EYE DISORDERS, PT: Lacrimation increased | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, Total | 15 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain lower | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain upper | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Constipation | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Diarrhoea | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Gastrooesophageal reflux disease | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Inguinal hernia | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Nausea | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Toothache | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, Total | 11 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Chest pain | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Fatigue | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Pyrexia | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, Total | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, PT: Liver injury | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, Total | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Cellulitis | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Conjunctivitis | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Influenza | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Molluscum contagiosum | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Nasopharyngitis | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Parainfluenzae virus infection | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Sinusitis | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Viral upper respiratory tract infection | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, Total | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Fall | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Joint dislocation | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Joint injury | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Post procedural contusion | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Skin abrasion | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, Total | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Amylase increased | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Complement factor C4 decreased | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Cystatin C increased | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Glutamate dehydrogenase increased | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Hepatic enzyme increased | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Lipase increased | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Troponin increased | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Decreased appetite | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Hyperuricaemia | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Arthralgia | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Back pain | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Myalgia | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Osteopenia | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Pain in extremity | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, Total | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Dizziness | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Headache | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Migraine | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Abnormal behaviour | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Affect lability | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Anxiety | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Irritability | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Mood altered | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Suicidal ideation | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 4 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Chronic kidney disease | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Glycosuria | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Haematuria | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Ketonuria | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Proteinuria | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, Total | 4 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Cough | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Epistaxis | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Oropharyngeal pain | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Rhinorrhoea | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Ecchymosis | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Rash | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Urticaria | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, PT: Hypertension | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain upper | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Decreased appetite | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain lower | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Glycosuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Ecchymosis | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Hyperuricaemia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Haematuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, Total | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Arthralgia | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: EYE DISORDERS, PT: Lacrimation increased | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Tooth abscess | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: EYE DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Ketonuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Myalgia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: ENDOCRINE DISORDERS, PT: Androgen deficiency | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: ENDOCRINE DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Proteinuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Pain in extremity | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiomyopathy | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Rash | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Dizziness | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Headache | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Lymphopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Skin abrasion | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Migraine | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Leukocytosis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Mass | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Cough | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Abnormal behaviour | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolysis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Procedural pain | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Affect lability | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Anaemia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, PT: Hypertension | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Anxiety | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Molluscum contagiosum | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Influenza | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Epistaxis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Nasopharyngitis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Irritability | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Parainfluenzae virus infection | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Sinusitis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Conjunctivitis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Cellulitis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Contusion | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Viral upper respiratory tract infection | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Mood altered | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, PT: Liver injury | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Fall | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Pyrexia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: SKIN AND SUBCUTANEOUS TISSUE DISORDERS, PT: Urticaria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Joint dislocation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Fatigue | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: PSYCHIATRIC DISORDERS, PT: Suicidal ideation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Joint injury | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Chest pain | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Ligament sprain | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Oropharyngeal pain | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INJURY, POISONING AND PROCEDURAL COMPLICATIONS, PT: Post procedural contusion | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Vomiting | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Infusion site reaction | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Toothache | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, Total | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Nausea | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Lethargy | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Amylase increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS, PT: Rhinorrhoea | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Complement factor C4 decreased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Cystatin C increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Inguinal hernia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Osteopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Glutamate dehydrogenase increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Gastrooesophageal reflux disease | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INFECTIONS AND INFESTATIONS, PT: Urinary tract infection | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Hepatic enzyme increased | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Diarrhoea | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Chronic kidney disease | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Lipase increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Constipation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS, PT: Back pain | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality TEAEs by System Organ Class (SOC) and Preferred Term (PT) for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Troponin increased | 1 Participants |
Primary
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a treatment-emergent AE (TEAE). A serious AE (SAE) was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. Severe AE=an event that prevents normal everyday activities.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | SAEs | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | TEAEs | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | Severe AEs | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | SAEs | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | TEAEs | 16 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | Severe AEs | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | TEAEs | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | Severe AEs | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs) for 1-Year Follow-Up | SAEs | 2 Participants |
Primary
Number of Participants With Electrocardiograms (ECGs) Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up
Triplicate ECG was performed after the participant had rested quietly for at least 10 minutes in a supine position. The pre-defined categorical criteria include PR interval aggregate (msec): value\>=300, baseline\>200 and percent change\>=25%, baseline\<=200 and percent change\>=50%; QRS duration aggregate (msec): value\>=140, percent change\>=50%; QTcF interval aggregate (msec): 450\<=value\<480, 480\<=value\<500, value\>=500, 30\<=change\<60, change\>=60. Only the category(ies) with at least 1 participant meeting the pre-defined criterion is/are reported for this outcome measure. Baseline for ECG was defined as the measurement before the Day 1 study drug administration.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Electrocardiograms (ECGs) Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Electrocardiograms (ECGs) Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Electrocardiograms (ECGs) Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry
Following parameters for clinical chemistry were analyzed for laboratory examination: blood urea nitrogen (BUN) and creatinine, glucose, calcium, sodium, potassium, chloride, total CO2 (bicarbonate), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (direct and indirect bilirubin), alkaline phosphatase, uric acid, albumin, total protein, serum phosphorus, cystatin C, creatine kinase, creatine kinase myocardial b fraction (CK-MB), amylase, lipase, gamma-glutamyl transferase (GGT), C-reactive protein (CRP), and cardiac troponin I. Laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Ferritin (ng/mL)>336.2 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glucose (mg/dL)>1.5x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Cystatin C (mg/L)>1.2x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>2.0x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bilirubin (mg/dL)>1.5x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Direct Bilirubin (mg/dL)>1.5x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Aspartate Aminotransferase (U/L)>3.0x ULN | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Alanine Aminotransferase (U/L)>3.0x ULN | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Gamma Glutamyl Transferase (U/L)>3.0x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Protein (g/dL)<0.8x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Albumin (g/dL)<0.8x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Urea Nitrogen (mg/dL)>1.3x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatinine (mg/dL)>1.3x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Urate (mg/dL)>1.2x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Sodium (mEq/L)<0.95x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Potassium (mEq/L)<0.9x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Calcium (mg/dL)<0.9x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Phosphate (mg/dL)<0.8x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bicarbonate (mEq/L)<0.9x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bicarbonate (mEq/L)>1.1x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatine Kinase (U/L)>2.0x ULN | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Triacylglycerol Lipase (U/L)>1.5x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | C-Reactive Protein High Sens (mg/dL)>1.1x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatine Kinase MB (ug/L)>2.0x ULN | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>1.0x ULN | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>3.0x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Ferritin (ng/mL)<23.9 | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Gamma Glutamyl Transferase (U/L)>3.0x ULN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>3.0x ULN | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Albumin (g/dL)<0.8x LLN | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Cystatin C (mg/L)>1.2x ULN | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Urea Nitrogen (mg/dL)>1.3x ULN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatinine (mg/dL)>1.3x ULN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Urate (mg/dL)>1.2x ULN | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatine Kinase MB (ug/L)>2.0x ULN | 16 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Sodium (mEq/L)<0.95x LLN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Potassium (mEq/L)<0.9x LLN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Direct Bilirubin (mg/dL)>1.5x ULN | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Calcium (mg/dL)<0.9x LLN | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>1.0x ULN | 10 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Phosphate (mg/dL)<0.8x LLN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bicarbonate (mEq/L)<0.9x LLN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Protein (g/dL)<0.8x LLN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>2.0x ULN | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glucose (mg/dL)>1.5x ULN | 4 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | C-Reactive Protein High Sens (mg/dL)>1.1x ULN | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bicarbonate (mEq/L)>1.1x ULN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Ferritin (ng/mL)<23.9 | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Ferritin (ng/mL)>336.2 | 11 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bilirubin (mg/dL)>1.5x ULN | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatine Kinase (U/L)>2.0x ULN | 16 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Aspartate Aminotransferase (U/L)>3.0x ULN | 16 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Alanine Aminotransferase (U/L)>3.0x ULN | 16 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Triacylglycerol Lipase (U/L)>1.5x ULN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Ferritin (ng/mL)>336.2 | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Gamma Glutamyl Transferase (U/L)>3.0x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>2.0x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | C-Reactive Protein High Sens (mg/dL)>1.1x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Protein (g/dL)<0.8x LLN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Albumin (g/dL)<0.8x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Calcium (mg/dL)<0.9x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bicarbonate (mEq/L)<0.9x LLN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Urea Nitrogen (mg/dL)>1.3x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Cystatin C (mg/L)>1.2x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Aspartate Aminotransferase (U/L)>3.0x ULN | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatinine (mg/dL)>1.3x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>3.0x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bilirubin (mg/dL)>1.5x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Urate (mg/dL)>1.2x ULN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glucose (mg/dL)>1.5x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Triacylglycerol Lipase (U/L)>1.5x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Sodium (mEq/L)<0.95x LLN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatine Kinase MB (ug/L)>2.0x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Ferritin (ng/mL)<23.9 | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Potassium (mEq/L)<0.9x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Direct Bilirubin (mg/dL)>1.5x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Bicarbonate (mEq/L)>1.1x ULN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Creatine Kinase (U/L)>2.0x ULN | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Alanine Aminotransferase (U/L)>3.0x ULN | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Phosphate (mg/dL)<0.8x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Clinical Chemistry | Glutamate Dehydrogenase (U/L)>1.0x ULN | 3 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology
Following hematologic parameters were analyzed for laboratory examination: hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell count, total neutrophils, absolute neutrophils (ANC), eosinophils, monocytes, basophils, lymphocytes, red blood cell indices, and haptoglobin. Laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils (10^3/mm3)<0.8x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Basophils (10^3/mm3)>1.2x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Platelets (10^3/mm3)<0.5x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Haptoglobin (mg/dL)>200 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes (10^3/mm3)>1.2x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Leukocytes (10^3/mm3)>1.5x Upper Limit of Normal (ULN) | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Prothrombin Time (sec)>1.1x ULN | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes (10^3/mm3)<0.8x LLN | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils (10^3/mm3)>1.2x ULN | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Activated Partial Thromboplastin Time (sec)>1.1x ULN | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils -TOTAL COUNT (10^3/mm3)>8.15 | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Erythrocyte Cell Morphology (No Unit)>0 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Hemoglobin (g/dL) <0.8x Lower Limit of Normal (LLN) | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils -TOTAL COUNT (10^3/mm3)<1.35 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Monocytes (10^3/mm3)>1.2x ULN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Hematocrit (%)<0.8x LLN | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes Atypical (10^3/mm3)>0 | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Eosinophils (10^3/mm3)>1.2x ULN | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Erythrocytes (10^6/mm3)<0.8x LLN | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils -TOTAL COUNT (10^3/mm3)<1.35 | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils (10^3/mm3)<0.8x LLN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils -TOTAL COUNT (10^3/mm3)>8.15 | 14 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Hemoglobin (g/dL) <0.8x Lower Limit of Normal (LLN) | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Hematocrit (%)<0.8x LLN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Erythrocytes (10^6/mm3)<0.8x LLN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Erythrocyte Cell Morphology (No Unit)>0 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Leukocytes (10^3/mm3)>1.5x Upper Limit of Normal (ULN) | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes (10^3/mm3)<0.8x LLN | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes (10^3/mm3)>1.2x ULN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes Atypical (10^3/mm3)>0 | 9 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils (10^3/mm3)>1.2x ULN | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils Band Form (10^3/mm3)>0.27 | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Basophils (10^3/mm3)>1.2x ULN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Eosinophils (10^3/mm3)>1.2x ULN | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Monocytes (10^3/mm3)>1.2x ULN | 12 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Activated Partial Thromboplastin Time (sec)>1.1x ULN | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Prothrombin Time (sec)>1.1x ULN | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Platelets (10^3/mm3)<0.5x LLN | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Myelocytes (10^3/mm3)>0 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Haptoglobin (mg/dL)<30 | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Haptoglobin (mg/dL)>200 | 10 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Hematocrit (%)<0.8x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Haptoglobin (mg/dL)<30 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Eosinophils (10^3/mm3)>1.2x ULN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Hemoglobin (g/dL) <0.8x Lower Limit of Normal (LLN) | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils -TOTAL COUNT (10^3/mm3)>8.15 | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Monocytes (10^3/mm3)>1.2x ULN | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils -TOTAL COUNT (10^3/mm3)<1.35 | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Leukocytes (10^3/mm3)>1.5x Upper Limit of Normal (ULN) | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Platelets (10^3/mm3)<0.5x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes (10^3/mm3)<0.8x LLN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Erythrocyte Cell Morphology (No Unit)>0 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Activated Partial Thromboplastin Time (sec)>1.1x ULN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils (10^3/mm3)<0.8x LLN | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes Atypical (10^3/mm3)>0 | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Haptoglobin (mg/dL)>200 | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils (10^3/mm3)>1.2x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Prothrombin Time (sec)>1.1x ULN | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Neutrophils Band Form (10^3/mm3)>0.27 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Erythrocytes (10^6/mm3)<0.8x LLN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Lymphocytes (10^3/mm3)>1.2x ULN | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Hematology | Basophils (10^3/mm3)>1.2x ULN | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis
Following parameters for urinalysis were analyzed for laboratory examination: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy. Laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Urine Microscopic Exam (Scalar)>=1 | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Hemoglobin (No Unit)>=1 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Erythrocytes (/high-powered field [HPF])>=20 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Nitrite (No Unit)>=1 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Protein (Scalar)>=1 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Calcium Oxalate Crystals (/LPF)>=0.5 | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Ketones (No Unit)>=1 | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Amorphous Crystals (/LPF)>=0.5 | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Calcium Oxalate Crystals (/LPF)>=0.5 | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Ketones (No Unit)>=1 | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Hemoglobin (No Unit)>=1 | 4 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Nitrite (No Unit)>=1 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Erythrocytes (/high-powered field [HPF])>=20 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Granular Casts (/low-power field [LPF])>1 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Hyaline Casts (/LPF)>1 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Uric Acid Crystals (/LPF)>=0.5 | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Protein (Scalar)>=1 | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Leukocytes (/HPF)>=20 | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Amorphous Crystals (/LPF)>=0.5 | 7 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Urine Microscopic Exam (Scalar)>=1 | 14 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Nitrite (No Unit)>=1 | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Hemoglobin (No Unit)>=1 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Ketones (No Unit)>=1 | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Leukocytes (/HPF)>=20 | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Urine Microscopic Exam (Scalar)>=1 | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Calcium Oxalate Crystals (/LPF)>=0.5 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | Amorphous Crystals (/LPF)>=0.5 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Protein (Scalar)>=1 | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality for 1-Year Follow-Up - Urinalysis | URINE Erythrocytes (/high-powered field [HPF])>=20 | 0 Participants |
Primary
Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
C-SSRS is a participant rated questionnaire to assess whether participant experienced the following: completed suicide(1), suicide attempt(2)(Yes on actual attempt), preparatory acts toward imminent suicidal behavior(3)(Yes on preparatory acts or behavior), suicidal ideation(4)(Yes on wish to be dead,non-specific active suicidal thoughts,active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(Yes on Has subject engaged in non-suicidal self-injurious behavior). Yes/No responses are mapped to C-CASA categories. C-SSRS was conducted with the participant's care giver/legal guardian on the participant's behalf throughout the study for participants\<=12 years of age at screening. Baseline is defined as the last predose measurement. Number of participants with responses of Yes is reported for this outcome measure.
Time frame: Baseline, Day 7, Day 14, Day 180, and Day 360
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <1> Completed Suicide | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <2> Suicide Attempt | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <4> Suicidal Ideation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <4> Suicidal Ideation | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <4> Suicidal Ideation | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 180: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 7: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <1> Completed Suicide | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <2> Suicide Attempt | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <4> Suicidal Ideation | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 14: Since Last Visit <3> Preparatory Acts towards Imminent Suicidal Behavior | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Baseline: Lifetime <7> Self-injurious behavior, no suicidal intent | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Positive Responses on Columbia-Suicide Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories | Day 360: Since Last Visit <2> Suicide Attempt | 0 Participants |
Primary
Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. An SAE was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-related AEs and SAEs were determined by the investigator. For this outcome measure, TEAEs were reported according to MedDRA version 25.0 SOC and PT.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related SAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
Primary
Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. For this outcome measure, TEAEs were reported according to MedDRA version 25.0 SOC and PT. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-related AEs were determined by the investigator.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Nausea | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Vomiting | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Decreased appetite | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Fatigue | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Glycosuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Infusion site reaction | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Anaemia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Troponin increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Pyrexia | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Proteinuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Lipase increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, PT: Liver injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Chronic kidney disease | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Hepatic enzyme increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Glutamate dehydrogenase increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Amylase increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Cystatin C increased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Complement factor C4 decreased | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Leukocytosis | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Diarrhoea | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Lymphopenia | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Lethargy | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolysis | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Headache | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Ketonuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Dizziness | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, PT: Hypertension | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, Total | 2 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain upper | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Haematuria | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Hyperuricaemia | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Dizziness | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolysis | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 9 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, Total | 11 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, Total | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Cystatin C increased | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 9 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Anaemia | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Leukocytosis | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Lymphopenia | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, Total | 15 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain upper | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Diarrhoea | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Nausea | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Vomiting | 13 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Fatigue | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Infusion site reaction | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Pyrexia | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, PT: Liver injury | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, Total | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Amylase increased | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Complement factor C4 decreased | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Glutamate dehydrogenase increased | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Hepatic enzyme increased | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Lipase increased | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Troponin increased | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 8 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Decreased appetite | 6 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Hyperuricaemia | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Headache | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Lethargy | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 4 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Chronic kidney disease | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Glycosuria | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Ketonuria | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Haematuria | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Proteinuria | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, Total | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, PT: Hypertension | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Decreased appetite | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Nausea | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, PT: Hypertension | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Dehydration | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Diarrhoea | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: VASCULAR DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, PT: Hyperuricaemia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Haematuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, PT: Cardiogenic shock | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Anaemia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Dizziness | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: CARDIAC DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Headache | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Lymphopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Ketonuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: NERVOUS SYSTEM DISORDERS, PT: Lethargy | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Leukocytosis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Abdominal pain upper | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolytic uraemic syndrome | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Thrombocytopenia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Acute kidney injury | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, PT: Haemolysis | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Complement factor C4 decreased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Amylase increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Cystatin C increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, Total | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Proteinuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Glutamate dehydrogenase increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, PT: Liver injury | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Chronic kidney disease | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Hepatic enzyme increased | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Pyrexia | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: BLOOD AND LYMPHATIC SYSTEM DISORDERS, Total | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Lipase increased | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Infusion site reaction | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, Total | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: INVESTIGATIONS, PT: Troponin increased | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS, PT: Fatigue | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: RENAL AND URINARY DISORDERS, PT: Glycosuria | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: METABOLISM AND NUTRITION DISORDERS, Total | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: GASTROINTESTINAL DISORDERS, PT: Vomiting | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs by SOC and PT for 1-Year Follow-Up | SOC: HEPATOBILIARY DISORDERS, Total | 1 Participants |
Primary
Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Any AE that started following start of treatment of PF-06939926 was counted as a TEAE. An SAE was an untoward medical occurrence that resulted in death, was life-threatening (immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect, or was considered to be an important medical event. Severe AE=an event that prevents normal everyday activities. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-related AEs and SAEs were determined by the investigator.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | SAEs | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | TEAEs | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | Severe AEs | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | SAEs | 3 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | TEAEs | 15 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | Severe AEs | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | TEAEs | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | Severe AEs | 2 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Treatment-Related TEAEs for 1-Year Follow-Up | SAEs | 2 Participants |
Primary
Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up
Vital signs consisted of blood pressure, respiratory rate, and heart rate, was obtained with these measurements at the following timepoints: within 30 minutes before and approximately 30 minutes, 1, 2, 4, 8, and 24 hours after the start of the infusion, and on Days 4, 7, 10, 14, 30, 90, 180, and 360. Baseline was defined as the last pre-dose recording. Number of participants who had at least 1 vital sign measurement at the specified timepoints meeting the pre-defined criteria from baseline up to the end of 1-year follow-up is reported for this outcome measure.
Time frame: Baseline up to 1 year post dose of PF-06939926
Population: Includes all enrolled participants who received PF-06939926. Participants were analyzed according to the intervention they actually received. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: increase>=20 mmHg | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: value<70 mmHg + 2*age for aged 2-10 years | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: decrease>=20 mmHg | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Respiratory Rate: value>22 breaths/min for aged 6-12 years | 3 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: decrease from baseline>=30 mmHg | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Heart Rate: value<40 beats per minute (bpm) | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Respiratory Rate: value<14 breaths/min for aged 6-12 years | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: value<50 mmHg | 1 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Heart Rate: value>120 bpm | 0 Participants |
| PF-06939926: Low Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: increase from baseline>=30 mmHg | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: value<90 mmHg for aged 11 years and older | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Heart Rate: value>120 bpm | 1 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: increase from baseline>=30 mmHg | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: decrease from baseline>=30 mmHg | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: value<50 mmHg | 5 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Respiratory Rate: value<14 breaths/min for aged 6-12 years | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Respiratory Rate: value>22 breaths/min for aged 6-12 years | 16 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: increase>=20 mmHg | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: decrease>=20 mmHg | 2 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: value<70 mmHg + 2*age for aged 2-10 years | 0 Participants |
| PF-06939926: High Dose, Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Heart Rate: value<40 beats per minute (bpm) | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Respiratory Rate: value<12 breaths/min for aged 13-18 years | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Heart Rate: value>120 bpm | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Respiratory Rate: value>20 breaths/min for aged 13-18 years | 3 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: value<50 mmHg | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: increase>=20 mmHg | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Diastolic Blood Pressure: decrease>=20 mmHg | 1 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Heart Rate: value<40 beats per minute (bpm) | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: value<90 mmHg for aged 11 years and older | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: increase from baseline>=30 mmHg | 0 Participants |
| PF-06939926: High Dose, Non-Ambulatory Cohort | Number of Participants With Vital Signs Meeting the Pre-Defined Categorical Criteria for 1-Year Follow-Up | Supine Systolic Blood Pressure: decrease from baseline>=30 mmHg | 0 Participants |