Trial Outcomes & Findings for A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults (NCT NCT05907395)
NCT ID: NCT05907395
Last Updated: 2025-04-10
Results Overview
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
Results posted on
2025-04-10
Participant Flow
A total of 30 participants (initially randomized participants and replacement participants) were enrolled in this study. All participants received at least 1 dose of study intervention and were assigned in the study into 3 cohorts. As planned, there were "replacement" participants in the study who were not initially randomized, but they replaced those participants who discontinued in any treatment period due to reasons other than safety; this was per investigator's and sponsor's discretion.
Participant milestones
| Measure |
Cohort 2: Sequence 1
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg. CRYS = crystalline form.
|
Cohort 2: Sequence 2
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): placebo matched to PF-07293893; then Period 4/Day1 (CRYS, fed): placebo matched to PF-07293893.
|
Cohort 1: Sequence 1
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): placebo matched to PF-07293893. SDD = spray dried dispersion form.
|
Cohort 1: Sequence 2
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg.
|
Cohort 1: Sequence 3
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg.
|
Cohort 1: Sequence 4
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg.
|
Cohort 2: Sequence 3
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (CRYS, fasted):PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg.
|
Cohort 2: Sequence 4
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF 07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg.
|
Cohort 3: Sequence 1
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg.
|
Cohort 3: Sequence 2
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg.
|
Cohort 3: Sequence 3
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg.
|
Cohort 3: Sequence 4
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): placebo matched to PF-07293893.
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Period 1
STARTED
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Period 1
COMPLETED
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1
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Period 1
NOT COMPLETED
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Period 2
STARTED
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Period 2
COMPLETED
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Period 2
NOT COMPLETED
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Period 3
STARTED
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Period 3
COMPLETED
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Period 3
NOT COMPLETED
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Period 4
STARTED
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Period 4
COMPLETED
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Period 4
NOT COMPLETED
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0
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Reasons for withdrawal
| Measure |
Cohort 2: Sequence 1
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg. CRYS = crystalline form.
|
Cohort 2: Sequence 2
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): placebo matched to PF-07293893; then Period 4/Day1 (CRYS, fed): placebo matched to PF-07293893.
|
Cohort 1: Sequence 1
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): placebo matched to PF-07293893. SDD = spray dried dispersion form.
|
Cohort 1: Sequence 2
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg.
|
Cohort 1: Sequence 3
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 10 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg.
|
Cohort 1: Sequence 4
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF-07293893 30 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 100 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 300 mg.
|
Cohort 2: Sequence 3
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (CRYS, fasted):PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg.
|
Cohort 2: Sequence 4
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF 07293893 1500 mg; then Period 3/Day1 (CRYS, fasted): PF-07293893 300 mg; then Period 4/Day1 (CRYS, fed): PF-07293893 300 mg.
|
Cohort 3: Sequence 1
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg.
|
Cohort 3: Sequence 2
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): placebo matched to PF-07293893; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg.
|
Cohort 3: Sequence 3
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): PF-07293893 750 mg; then Period 2/Day 1 (SDD, fasted): placebo matched to PF-07293893; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): PF-07293893 750 mg.
|
Cohort 3: Sequence 4
Participants received treatment as oral suspension in all periods. Period 1/Day1 (SDD, fed): placebo matched to PF-07293893; then Period 2/Day 1 (SDD, fasted): PF-07293893 1200 mg; then Period 3/Day1 (SDD, fasted): PF-07293893 900 mg; then Period 4/Day1 (SDD, fasted): placebo matched to PF-07293893.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Period 1
No longer met eligibility criteria
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0
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1
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0
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1
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0
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0
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1
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0
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0
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0
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0
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0
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Period 2
Adverse Event
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0
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0
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0
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0
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0
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1
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0
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1
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0
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0
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0
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0
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Period 2
Personal reason
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Period 3
Adverse Event
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
A Study to Learn About the Study Medicine (PF-07293893) at Different Dose Levels in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
In this cohort participants were randomized to received placebo matched to PF-07293893 or PF-07293893 (10 mg, 30 mg, 100 mg or 300 mg) in sequence 1 or 2 or 3 or 4.
|
Cohort 2
n=11 Participants
In this cohort participants were randomized to received placebo matched to PF-07293893 or PF-07293893 (300mg \[fast/fed\],750 mg, 1500 mg) in sequence 1 or 2 or 3 or 4.
|
Cohort 3
n=9 Participants
In this cohort participants were randomized to received placebo matched to PF-07293893 or PF-07293893 (750 mg \[fast/fed\], 900 mg, 1200 mg) in sequence 1 or 2 or 3 or 4.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
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1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
Age · 18-44 Years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Customized
Age · 45-64 Years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Customized
Age · >=65 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
An Adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events with onset dates on or after the start of the study drug.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
n=18 Participants
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Following parameters were analyzed for laboratory abnormalities: hematology (lymphocytes \<0.8\*lower limit of normal \[LLN\], lymphocytes/leukocytes \<0.8\*LLN, neutrophils \<0.8\*LLN, neutrophils/leukocytes \<0.8\*LLN, eosinophils/leukocytes \>1.2\*upper limit of normal \[ULN\], monocytes \>1.2\*ULN, monocytes/leukocytes \>1.2\*ULN); clinical chemistry (aspartate aminotransferase \>3.0\*ULN, potassium \>1.1\*ULN, creatine kinase \>2.0\*ULN); urinalysis (urine specific gravity \<1.003 ,\>1.030, ketones \>=1, urine hemoglobin \>=1, urobilinogen \>=1, urine bilirubin \>=1, leukocyte esterase \>=1). In this outcome measure, participants with any laboratory abnormalities are reported.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
n=18 Participants
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Vital signs assessments included blood pressure, pulse rate, respiratory rate and body temperature. Clinical significance of vital signs was determined based by investigator's discretion.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
n=18 Participants
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 of first dose up to maximum of 9 days post last dose (up to 34 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
ECG parameters included heart rate, PR interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. Clinically significant ECG findings were determined by the investigator's discretion.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
n=18 Participants
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
n=2 Participants
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment periodPopulation: Pharmacokinetic (PK) parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-07293893
|
6831 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 9
|
110.2 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 39
|
360.1 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 19
|
1173 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 24
|
147.2 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 20
|
690.6 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 23
|
3613 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 34
|
5632 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 28
|
6203 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 22
|
5653 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 33
|
7894 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 15
|
7458 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 18
|
7398 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment periodPopulation: PK parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-07293893
|
2.50 Hour
Interval 1.0 to 6.22
|
1.00 Hour
Interval 1.0 to 1.03
|
1.01 Hour
Interval 1.0 to 1.03
|
2.03 Hour
Interval 1.0 to 3.0
|
2.50 Hour
Interval 1.0 to 4.03
|
6.00 Hour
Interval 4.0 to 8.0
|
2.51 Hour
Interval 2.0 to 3.0
|
3.51 Hour
Interval 2.0 to 4.0
|
3.01 Hour
Interval 1.0 to 6.22
|
5.00 Hour
Interval 4.0 to 6.0
|
4.00 Hour
Interval 3.0 to 6.0
|
4.00 Hour
Interval 3.0 to 6.03
|
4.01 Hour
Interval 3.0 to 6.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment periodPopulation: PK Parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
AUClast was calculated using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07293893
|
89220 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 17
|
782.5 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 37
|
2671 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 11
|
8354 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 24
|
2057 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 19
|
8910 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 30
|
29900 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 25
|
50150 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 37
|
66890 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 42
|
80700 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 48
|
100700 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 20
|
103400 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 30
|
94210 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment periodPopulation: PK Parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07293893
|
89780 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 17
|
799.3 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 36
|
2700 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 11
|
8397 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 24
|
2219 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 20
|
9001 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 30
|
30010 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 25
|
50280 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 37
|
67190 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 42
|
81070 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 49
|
101200 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 21
|
103900 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 30
|
94570 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 48 and 72 hours post dose of any treatment periodPopulation: PK Parameter Set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
t1/2 was calculated as log\^e (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Outcome measures
| Measure |
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 Participants
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 Participants
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 Participants
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 Participants
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 Participants
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of PF-07293893
|
11.00 Hour
Standard Deviation 1.3977
|
13.88 Hour
Standard Deviation 2.8160
|
15.32 Hour
Standard Deviation 1.4386
|
13.92 Hour
Standard Deviation 2.0673
|
21.50 Hour
Standard Deviation 6.5593
|
13.70 Hour
Standard Deviation 1.2767
|
11.34 Hour
Standard Deviation 2.1157
|
10.07 Hour
Standard Deviation 3.0057
|
10.54 Hour
Standard Deviation 2.2872
|
10.90 Hour
Standard Deviation 1.2152
|
10.76 Hour
Standard Deviation 1.3132
|
10.44 Hour
Standard Deviation 2.1452
|
9.578 Hour
Standard Deviation 1.1218
|
—
|
—
|
—
|
—
|
Adverse Events
PF-07293893 10 mg: SDD/Fasted Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07293893 30 mg: SDD/Fasted Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-07293893 100 mg: SDD/Fasted Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07293893 300 mg: CRYS/Fasted Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-07293893 300 mg: CRYS/Fed Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07293893 300 mg: SDD/Fasted Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07293893 750 mg: SDD/Fasted Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07293893 750 mg: SDD/Fasted Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-07293893 750 mg: SDD/Fed Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-07293893 900 mg: SDD/Fasted Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-07293893 1200 mg: SDD/Fasted Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07293893 1500 mg: SDD/Fasted Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo: CRYS/Fasted Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo: CRYS/Fed Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo: SDD/Fasted Combined for All Cohorts
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo: SDD/Fed Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-07293893 10 mg: SDD/Fasted Cohort 1
n=6 participants at risk
Participants received PF-07293893 SDD 10 mg in fasted condition.
|
PF-07293893 30 mg: SDD/Fasted Cohort 1
n=6 participants at risk
Participants received PF-07293893 SDD 30 mg in fasted condition.
|
PF-07293893 100 mg: SDD/Fasted Cohort 1
n=6 participants at risk
Participants received PF-07293893 SDD100 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fasted Cohort 2
n=6 participants at risk
Participants received PF-07293893 CRYS 300 mg in fasted condition.
|
PF-07293893 300 mg: CRYS/Fed Cohort 2
n=5 participants at risk
Participants received PF-07293893 CRYS 300 mg in fed condition.
|
PF-07293893 300 mg: SDD/Fasted Cohort 1
n=6 participants at risk
Participants received PF-07293893 SDD 300 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 2
n=6 participants at risk
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Cohort 3
n=6 participants at risk
Participants received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fasted Combined for Cohorts 2 and 3
n=12 participants at risk
Participants who received PF-07293893 SDD 750 mg in fasted condition.
|
PF-07293893 750 mg: SDD/Fed Cohort 3
n=6 participants at risk
Participants received PF-07293893 SDD 750 mg in fed condition.
|
PF-07293893 900 mg: SDD/Fasted Cohort 3
n=6 participants at risk
Participants received PF-07293893 SDD 900 mg in fasted condition.
|
PF-07293893 1200 mg: SDD/Fasted Cohort 3
n=6 participants at risk
Participants received PF-07293893 SDD 1200 mg in fasted condition.
|
PF-07293893 1500 mg: SDD/Fasted Cohort 2
n=6 participants at risk
Participants received PF-07293893 SDD 1500 mg in fasted condition.
|
Placebo: CRYS/Fasted Cohort 2
n=2 participants at risk
Participants received placebo matched to PF-07293893 CRYS in fasted condition.
|
Placebo: CRYS/Fed Cohort 2
n=2 participants at risk
Participants received placebo matched to PF-07293893 CRYS in fed condition.
|
Placebo: SDD/Fasted Combined for All Cohorts
n=18 participants at risk
Participants received placebo matched to PF-07293893 SDD in fasted condition.
|
Placebo: SDD/Fed Cohort 2
n=2 participants at risk
Participants received placebo matched to PF-07293893 SDD in fed condition.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
8.3%
1/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
5.6%
1/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
33.3%
2/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
2/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Application site irritation
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Asthenia
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Fatigue
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
5.6%
1/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Feeling cold
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
5.6%
1/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
5.6%
1/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
5.6%
1/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Investigations
Liver function test increased
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
8.3%
1/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
33.3%
2/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
66.7%
4/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
6/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
33.3%
2/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
33.3%
2/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
66.7%
4/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
50.0%
1/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
11.1%
2/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
8.3%
1/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
33.3%
2/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
8.3%
1/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
20.0%
1/5 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/12 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
16.7%
1/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/6 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/18 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
0.00%
0/2 • Day 1 of first dose up to maximum of 35 days post last dose (up to 60 days)
|
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