Trial Outcomes & Findings for A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults (NCT NCT05890105)
NCT ID: NCT05890105
Last Updated: 2025-01-03
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Day 1-11 in each period, along with the 29-36 day post final dose follow-up
Results posted on
2025-01-03
Participant Flow
A total of 23 participants were enrolled, and received at least 1 dose of study intervention.
Participant milestones
| Measure |
Cohort 1
Cohort 1 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted-\>PF-07853578 10 mg \[10 mg\]-\>100 mg-\>500 mg; 1 mg (low dosage strength \[LDS\])-\>Placebo Fasted-\>100 mg-\>500 mg; 1 mg (LDS)-\>10 mg-\>Placebo Fasted-\>500 mg; and 1 mg (LDS)-\>10 mg-\>100 mg-\>Placebo Fasted
|
Cohort 2
Cohort 2 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted-\>30 mg-\>300 mg-\>300 mg Fed; 3 mg-\>Placebo Fasted-\>300 mg-\>300 mg fed; 3 mg-\>30 mg-\>Placebo Fasted-\>Placebo Fed; and 3 mg-\>30 mg-\>300 mg-\>300 mg fed
|
Cohort 3
Cohort 3 included 2 sequences, each sequence of which included 2 treatment periods: Placebo Fasted-\>Placebo Fasted; and 8 mg-\>8 mg (intermediate dosage strength \[IDS\])
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Cohort 1 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted-\>PF-07853578 10 mg \[10 mg\]-\>100 mg-\>500 mg; 1 mg (low dosage strength \[LDS\])-\>Placebo Fasted-\>100 mg-\>500 mg; 1 mg (LDS)-\>10 mg-\>Placebo Fasted-\>500 mg; and 1 mg (LDS)-\>10 mg-\>100 mg-\>Placebo Fasted
|
Cohort 2
Cohort 2 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted-\>30 mg-\>300 mg-\>300 mg Fed; 3 mg-\>Placebo Fasted-\>300 mg-\>300 mg fed; 3 mg-\>30 mg-\>Placebo Fasted-\>Placebo Fed; and 3 mg-\>30 mg-\>300 mg-\>300 mg fed
|
Cohort 3
Cohort 3 included 2 sequences, each sequence of which included 2 treatment periods: Placebo Fasted-\>Placebo Fasted; and 8 mg-\>8 mg (intermediate dosage strength \[IDS\])
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
2
|
0
|
Baseline Characteristics
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
Cohort 1 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted-\>PF-07853578 10 mg \[10 mg\]-\>100 mg-\>500 mg; 1 mg (low dosage strength \[LDS\])-\>Placebo Fasted-\>100 mg-\>500 mg; 1 mg (LDS)-\>10 mg-\>Placebo Fasted-\>500 mg; and 1 mg (LDS)-\>10 mg-\>100 mg-\>Placebo Fasted
|
Cohort 2
n=8 Participants
Cohort 2 included 4 sequences, each sequence of which included 4 treatment periods: Placebo Fasted-\>30 mg-\>300 mg-\>300 mg Fed; 3 mg-\>Placebo Fasted-\>300 mg-\>300 mg fed; 3 mg-\>30 mg-\>Placebo Fasted-\>Placebo Fed; and 3 mg-\>30 mg-\>300 mg-\>300 mg fed
|
Cohort 3
n=7 Participants
Cohort 3 included 2 sequences, each sequence of which included 2 treatment periods: Placebo Fasted-\>Placebo Fasted; and 8 mg-\>8 mg (intermediate dosage strength \[IDS\])
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-44 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Customized
45-64 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 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/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1-11 in each period, along with the 29-36 day post final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
n=14 Participants
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
n=1 Participants
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
All-causality AEs
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Treatment-related AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
All-causality SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Treatment-related SAEs
|
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 1-11 in each period, along with the 29-36 day post final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Pre-defined categorical criteria for laboratory abnormalities included: Lymphocytes \<0.8 x lower limit of normal (LLN); Basophils/Leukocytes \> 1.2 x upper limit of normal (ULN); Eosinophils/Leukocytes \>1.2 x ULN; Monocytes/Leukocytes \>1.2 x ULN; low-density lipoprotein (LDL) Direct Endpoint Measure \>1.2 x ULN; Triglycerides \>1.3 x ULN; Specific Gravity \<1.003 or \>1.030; pH \>8; Ketones ≥1; Urobilinogen (EU) ≥1; URINE Bilirubin ≥1; Leukocyte Esterase ≥1.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
n=14 Participants
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
n=1 Participants
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1-11 in each period, along with the 29-36 day post final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
n=14 Participants
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
n=1 Participants
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Pulse rate < 40 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Pulse rate > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
SBP <90 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in SBP ≥30 mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in SBP ≥30 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
DBP <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in DBP ≥20 increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in DBP ≥20 decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1-11 in each period, along with the 29-36 day post final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec, c) ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
n=14 Participants
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
n=1 Participants
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
|
0 Participants
|
1 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) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)Population: 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.
Maximum observed plasma PF-07328948 concentration. Observed directly from data.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration Observed in Plasma (Cmax)
|
7.196 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
7.226 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
14.87 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 66
|
41.92 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
17.92 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
43.91 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
119.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
355.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
690.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53
|
449.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)Population: 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.
Observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve Cmax (Tmax)
|
0.500 hours (hr)
Interval 0.5 to 1.0
|
1.08 hours (hr)
Interval 0.5 to 1.17
|
1.00 hours (hr)
Interval 0.5 to 1.0
|
0.517 hours (hr)
Interval 0.5 to 0.517
|
1.00 hours (hr)
Interval 0.5 to 2.0
|
2.00 hours (hr)
Interval 1.0 to 2.0
|
3.00 hours (hr)
Interval 2.0 to 3.02
|
2.00 hours (hr)
Interval 1.0 to 3.0
|
4.00 hours (hr)
Interval 2.0 to 6.0
|
3.02 hours (hr)
Interval 2.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)Population: 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.
Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast)
|
17.03 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
43.52 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 77
|
105.8 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
111.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 44
|
153.3 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
462.4 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
1825 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
4590 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 58
|
6747 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66
|
7774 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)Population: 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.
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
|
18.29 ng*hr/mL
Geometric Coefficient of Variation 31
|
46.69 ng*hr/mL
Geometric Coefficient of Variation 73
|
111.5 ng*hr/mL
Geometric Coefficient of Variation 60
|
114.1 ng*hr/mL
Geometric Coefficient of Variation 44
|
157.0 ng*hr/mL
Geometric Coefficient of Variation 33
|
470.6 ng*hr/mL
Geometric Coefficient of Variation 55
|
1876 ng*hr/mL
Geometric Coefficient of Variation 29
|
4649 ng*hr/mL
Geometric Coefficient of Variation 59
|
6822 ng*hr/mL
Geometric Coefficient of Variation 67
|
8066 ng*hr/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours post Day 1 dosing of each treatment period (Periods 1-4)Population: 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.
Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Outcome measures
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 Participants
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 Participants
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 Participants
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 Participants
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 Participants
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 Participants
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 Participants
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 Participants
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 Participants
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 Participants
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2)
|
5.748 hours (hr)
Standard Deviation 4.1227
|
12.78 hours (hr)
Standard Deviation 3.6983
|
15.19 hours (hr)
Standard Deviation 7.1273
|
8.692 hours (hr)
Standard Deviation 2.4278
|
11.26 hours (hr)
Standard Deviation 4.7825
|
13.15 hours (hr)
Standard Deviation 2.5990
|
13.00 hours (hr)
Standard Deviation 3.8601
|
10.44 hours (hr)
Standard Deviation 2.7311
|
11.28 hours (hr)
Standard Deviation 2.7070
|
14.38 hours (hr)
Standard Deviation 3.0237
|
—
|
—
|
Adverse Events
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
3 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
8 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
8 mg (Intermediate Dosage Strength [IDS] Solution)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 mg Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
500 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-07853578 1 mg (1mg) (Low Dosage Strength [LDS] Solution)
n=5 participants at risk
Participants in Cohort 1 received 1 mg (LDS Solution).
|
3 mg
n=6 participants at risk
Participants in Cohort 2 received 3 mg.
|
8 mg
n=5 participants at risk
Participants in Cohort 3 received 8 mg.
|
8 mg (Intermediate Dosage Strength [IDS] Solution)
n=5 participants at risk
Participants in Cohort 3 received 8 mg (IDS Solution)
|
10 mg
n=5 participants at risk
Participants in Cohort 1 received 10 mg.
|
30 mg
n=6 participants at risk
Participants in Cohort 2 received 30 mg.
|
100 mg
n=5 participants at risk
Participant in Cohort 1 received 100 mg.
|
300 mg
n=6 participants at risk
Participants in Cohort 2 received 300 mg.
|
300 mg Fed
n=5 participants at risk
Participants in Cohort 2 received 300 mg Fed.
|
500 mg
n=4 participants at risk
Participants in Cohort 1 received 500 mg.
|
Placebo Fasted
n=14 participants at risk
Participants in Cohorts 1, 2, and 3 received Placebo Fasted.
|
Placebo Fed
n=1 participants at risk
Participants in Cohort 2 received Placebo Fed.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Application site irritation
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling hot
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.1%
1/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/14 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/1 • Day 1-11 in each period, along with the 29-36 day post final dose follow-up
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place