Trial Outcomes & Findings for A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age (NCT NCT05650333)
NCT ID: NCT05650333
Last Updated: 2024-10-08
Results Overview
Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7.
COMPLETED
PHASE1
15 participants
Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose]
2024-10-08
Participant Flow
A total of 15 participants, 6 to less than 12 years of age with greater than or equal to (\>=) 50% scalp hair loss due to alopecia areata, were enrolled. Study started from 02 March 2023 and completed on 11 August 2023.
Participant milestones
| Measure |
Ritlecitinib 20 mg
Participants received Ritlecitinib 20 milligram (mg) orally once daily (QD), for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Treatment Period (7 Days)
STARTED
|
15
|
|
Treatment Period (7 Days)
COMPLETED
|
14
|
|
Treatment Period (7 Days)
NOT COMPLETED
|
1
|
|
Follow-up (35 Days After Last Dose)
STARTED
|
15
|
|
Follow-up (35 Days After Last Dose)
COMPLETED
|
15
|
|
Follow-up (35 Days After Last Dose)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Ritlecitinib 20 mg
Participants received Ritlecitinib 20 milligram (mg) orally once daily (QD), for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Treatment Period (7 Days)
Adverse Event
|
1
|
Baseline Characteristics
A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age
Baseline characteristics by cohort
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Age, Continuous
|
8.5 Years
STANDARD_DEVIATION 1.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose]Population: Pharmacokinetic (PK) parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.
Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=13 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7
|
437.5 Nanogram*hours per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30 • Interval 30.0 to
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=13 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib
|
208.7 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38 • Interval 38.0 to
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=13 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib
|
0.500 Hours
Full Range 0.450 • Interval 0.45 to 1.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=13 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Apparent Oral Clearance (CL/F) of Ritlecitinib
|
45.70 Liter per hour (L/hr)
Geometric Coefficient of Variation 30 • Interval 30.0 to
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=8 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Apparent Volume of Distribution (Vz/F) of Ritlecitinib
|
74.92 Liter
Geometric Coefficient of Variation 23 • Interval 23.0 to
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7Population: PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). "Number of Participants Analyzed": participants evaluable for the outcome measure.
Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=8 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Elimination Half-Life (t1/2) of Ritlecitinib
|
1.191 Hours
Standard Deviation 0.10776 • Interval 0.10776 to
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The pharmacodynamic (PD) parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7
Baseline
|
121.0 Picogram per milliliter (pg/mL)
Interval 74.7 to 888.0
|
|
Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7
Change at Day 7
|
-9.9 Picogram per milliliter (pg/mL)
Interval -555.0 to 104.0
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Change From Baseline in T Lymphocytes on Day 7
CD8 T cytotoxic lymphocytes: Change at Day 7
|
0.0 10^9 cells per liter
Interval -0.6 to 0.8
|
|
Change From Baseline in T Lymphocytes on Day 7
CD3 cells: Baseline
|
1.8 10^9 cells per liter
Interval 0.8 to 3.4
|
|
Change From Baseline in T Lymphocytes on Day 7
CD3 cells: Change at Day 7
|
-0.0 10^9 cells per liter
Interval -1.3 to 2.0
|
|
Change From Baseline in T Lymphocytes on Day 7
CD4 T helper lymphocytes: Baseline
|
1.0 10^9 cells per liter
Interval 0.6 to 1.6
|
|
Change From Baseline in T Lymphocytes on Day 7
CD4 T helper lymphocytes: Change at Day 7
|
-0.1 10^9 cells per liter
Interval -0.6 to 1.1
|
|
Change From Baseline in T Lymphocytes on Day 7
CD8 T cytotoxic lymphocytes: Baseline
|
0.6 10^9 cells per liter
Interval 0.2 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
B lymphocytes included CD19 cells.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Change From Baseline in B Lymphocytes on Day 7
Baseline
|
439.0 10^6 cells per liter
Interval 191.0 to 881.0
|
|
Change From Baseline in B Lymphocytes on Day 7
Change at Day 7
|
-19.0 10^6 cells per liter
Interval -116.0 to 766.0
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Change From Baseline in Natural Killer (NK) Cells on Day 7
Baseline
|
254.0 10^6 cells per liter
Interval 85.0 to 729.0
|
|
Change From Baseline in Natural Killer (NK) Cells on Day 7
Change at Day 7
|
-25.5 10^6 cells per liter
Interval -318.0 to 627.0
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness was judged by investigator.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants With Treatment Related AEs
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42)Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants With Serious AEs (SAEs)
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 7Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants With AEs Leading to Treatment Discontinuation
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 7Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 7Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention.
Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance of any laboratory abnormality was judged by investigator.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=15 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and 7Population: Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
The pediatric taste questionnaire included 3 questions regarding: 1) Overall Taste (likeability in tase), 2) Overall Mouthfeel (how the medicine felt) and 3) Overall Volume of Medicine (likeability of the amount of medicine). Each question ranged from 1 (most favorable) to 5 (least favorable), higher scores indicates less liking to medicine. Ritlecitinib was provided as capsules; for administration, the capsules were dissolved in water and the contents of the capsule in water were taken according to the dosing administration instructions.
Outcome measures
| Measure |
Ritlecitinib 20 mg
n=14 Participants
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Taste Score · 1
|
1 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Taste Score · 3
|
3 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Taste Score · 2
|
1 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Volume Score · 4
|
1 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Taste Score · 2
|
0 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Taste Score · 4
|
3 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Taste Score · 5
|
7 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Mouthfeel Score · 1
|
0 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Mouthfeel Score · 2
|
5 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Mouthfeel Score · 3
|
3 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Mouthfeel Score · 4
|
4 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Mouthfeel Score · 5
|
2 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Volume Score · 1
|
2 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Volume Score · 2
|
5 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Volume Score · 3
|
2 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Volume Score · 4
|
2 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 1: Volume Score · 5
|
3 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Taste Score · 1
|
0 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Taste Score · 3
|
4 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Taste Score · 4
|
2 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Taste Score · 5
|
7 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Mouthfeel Score · 1
|
0 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Mouthfeel Score · 2
|
5 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Mouthfeel Score · 3
|
3 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Mouthfeel Score · 4
|
5 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Mouthfeel Score · 5
|
1 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Volume Score · 1
|
1 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Volume Score · 2
|
6 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Volume Score · 3
|
2 Participants
|
|
Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire
Day 7: Volume Score · 5
|
4 Participants
|
Adverse Events
Ritlecitinib 20 mg QD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ritlecitinib 20 mg QD
n=15 participants at risk
Participants received Ritlecitinib 20 mg orally QD, for 7 consecutive days. Participants were followed up to 35 days after the last dose.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Day 1 up to 35 days after last dose (maximum up to Day 42)
Safety set evaluated.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Day 1 up to 35 days after last dose (maximum up to Day 42)
Safety set evaluated.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 1 • Day 1 up to 35 days after last dose (maximum up to Day 42)
Safety set evaluated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • Day 1 up to 35 days after last dose (maximum up to Day 42)
Safety set evaluated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER