Trial Outcomes & Findings for 4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes (NCT NCT03538743)
NCT ID: NCT03538743
Last Updated: 2020-07-01
Results Overview
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
98 participants
Primary outcome timeframe
From baseline to up to 35 days after last dose for a total of approximately 63 days
Results posted on
2020-07-01
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to PF-06882961 was administered orally once daily (QD) or twice daily (BID) (dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID Slow Titration (ST)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD Controlled Release (CR)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
9
|
9
|
10
|
9
|
9
|
9
|
8
|
10
|
|
Overall Study
Received Treatment
|
25
|
9
|
9
|
10
|
9
|
9
|
9
|
8
|
10
|
|
Overall Study
COMPLETED
|
25
|
9
|
8
|
8
|
9
|
9
|
9
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to PF-06882961 was administered orally once daily (QD) or twice daily (BID) (dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID Slow Titration (ST)
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD Controlled Release (CR)
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Non-Treatment-Related Reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 Participants
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
|
Age, Customized
45-64 years
|
19 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
77 Participants
n=62 Participants
|
|
Age, Customized
>=65 years
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
17 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
47 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
51 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
61 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
37 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
70 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
27 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
|
Age Range
|
60.0 Years
n=93 Participants
|
55.0 Years
n=4 Participants
|
55.0 Years
n=27 Participants
|
63.5 Years
n=483 Participants
|
60.0 Years
n=36 Participants
|
57.0 Years
n=10 Participants
|
58.0 Years
n=115 Participants
|
58.0 Years
n=40 Participants
|
59.0 Years
n=8 Participants
|
58.0 Years
n=62 Participants
|
PRIMARY outcome
Timeframe: From baseline to up to 35 days after last dose for a total of approximately 63 daysPopulation: All randomized participants who received at least 1 dose of randomized study treatment.
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 Participants
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Treatment-related AE
|
14 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
All-causality AE
|
17 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
All-causality SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
Treatment-related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to up to 14 days after last dose for a total of approximately 42 daysPopulation: All randomized participants who received at least 1 dose of randomized study treatment.
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 Participants
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
|
24 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From baseline to up to 14 days after last dose for a total of approximately 42 daysPopulation: All randomized participants who received at least 1 dose of randomized study treatment.
Vital signs categorical summarization 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 |
Placebo
n=25 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 Participants
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs
Supine pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine SBP <90 mmHg
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine SBP increase >=30 mmHg
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine SBP decrease >=30 mmHg
|
9 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine DBP <50 mmHg
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine DBP increase >=20 mmHg
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine DBP decrease >=20 mmHg
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Vital Signs
Supine pulse rate <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to up to 14 days after last dose for a total of approximately 42 daysPopulation: All randomized participants who received at least 1 dose of randomized study treatment.
ECG categorical summarization 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) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2\. QRS duration (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 |
Placebo
n=25 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 Participants
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
PR interval ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
%Change in PR interval ≥25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
QRS duration ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
%Change in QRS duration ≥50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
QTcF interval >450 and ≤480 msec
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
QTcF interval >480 and ≤500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
QTcF interval >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
Change in QTcF interval >30 and ≤60 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
Change in QTcF interval >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28Population: All randomized participants who received at least 1 dose of PF-06882961 and who had at least 1 of the PK parameters of interest.
Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=10 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUC24 on Day 1
|
707.5 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 43
|
1502 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 29
|
645.8 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 52
|
666.1 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 54
|
178.7 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 72
|
324.0 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 41
|
393.9 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 80
|
184.6 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 49
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUCtau1 on Day 1
|
288.1 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 37
|
741.4 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 35
|
279.7 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 49
|
260.3 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 45
|
74.50 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 66
|
147.7 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 43
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUCtau2 on Day 1
|
414.8 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 50
|
678.5 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 79
|
364.9 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 56
|
401.9 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 62
|
103.7 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 76
|
176.4 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 42
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUC24 on Day 14 or 21
|
853.8 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 45
|
2092 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 91
|
2988 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 59
|
8149 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 84
|
201.6 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 63
|
2660 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 76
|
1291 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 68
|
1204 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 43
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUCtau1 on Day 14 or 21
|
348.6 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 48
|
880.3 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 78
|
1462 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 70
|
3772 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 85
|
85.57 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 59
|
957.3 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 66
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUCtau2 on Day 14 or 21
|
500.1 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 46
|
1175 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 110
|
1517 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 53
|
4361 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 89
|
115.4 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 68
|
1693 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 83
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUC24 on Day 28
|
876.7 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 41
|
1653 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 55
|
3171 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 56
|
8368 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 79
|
455.9 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 66
|
5973 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 87
|
4372 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 31
|
2723 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 39
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUCtau1 on Day 28
|
331.1 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 40
|
671.1 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 35
|
1153 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 44
|
3534 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 87
|
190.8 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 60
|
2249 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 88
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
—
|
|
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
AUCtau2 on Day 28
|
534.7 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 46
|
960.1 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 73
|
1970 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 68
|
4852 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 74
|
261.0 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 72
|
3668 nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation 91
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
NA nanogram.hours/milliliter (ng.h/mL)
Geometric Coefficient of Variation NA
Data was calculated as AUC24 only for QD dosing.
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28Population: All randomized participants treated who had at least 1 measurable concentration value.
For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2. Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours. Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=10 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax1 on Day 28
|
50.24 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
103.8 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
197.9 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
649.2 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 90
|
30.42 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
357.1 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 84
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax on Day 1
|
50.58 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
124.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
49.75 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
51.61 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
15.02 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 70
|
26.02 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
28.67 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 87
|
20.40 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax1 on Day 1
|
42.69 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
119.1 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
45.01 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
36.51 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
12.82 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
24.06 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax2 on Day 1
|
40.63 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 66
|
68.77 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
42.33 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 59
|
44.97 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 61
|
13.98 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 75
|
21.64 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax on Day 14 or 21
|
65.78 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
149.8 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 88
|
253.6 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 76
|
788.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 89
|
18.63 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
188.5 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
98.11 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 54
|
100.7 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax1 on Day 14 or 21
|
55.00 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
130.2 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 85
|
235.1 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 84
|
682.7 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 92
|
15.31 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
143.0 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 71
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax2 on Day 14 or 21
|
63.89 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
127.9 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 86
|
202.8 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
505.3 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 93
|
17.16 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
178.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax on Day 28
|
81.56 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
133.7 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 69
|
328.8 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
685.2 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 87
|
38.38 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
437.6 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 94
|
303.9 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
192.2 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Cmax2 on Day 28
|
74.22 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
117.2 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
306.5 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
617.9 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 93
|
35.01 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
410.3 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 90
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Data was calculated as Cmax only for QD dosing.
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28Population: All participants randomized and treated who had at least 1 of the PK parameters of interest.
Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=10 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax on Day 28
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
14.0 hours
Interval 8.0 to 14.0
|
10.0 hours
Interval 6.0 to 14.0
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax2 on Day 28
|
12.0 hours
Interval 12.0 to 14.0
|
12.0 hours
Interval 12.0 to 12.0
|
12.0 hours
Interval 12.0 to 14.0
|
12.0 hours
Interval 12.0 to 14.0
|
12.0 hours
Interval 12.0 to 14.0
|
12.0 hours
Interval 10.0 to 14.0
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax on Day 1
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
13.0 hours
Interval 8.0 to 23.9
|
3.00 hours
Interval 1.0 to 6.0
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax1 on Day 1
|
4.00 hours
Interval 2.0 to 8.0
|
4.00 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 1.0 to 6.0
|
4.00 hours
Interval 2.0 to 6.0
|
2.00 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 1.0 to 4.0
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax2 on Day 1
|
14.0 hours
Interval 10.0 to 24.0
|
14.0 hours
Interval 10.0 to 24.0
|
14.0 hours
Interval 12.0 to 14.0
|
14.0 hours
Interval 12.0 to 24.0
|
12.0 hours
Interval 12.0 to 14.0
|
14.0 hours
Interval 12.0 to 24.0
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax on Day 14 or 21
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
NA hours
Data was calculated as Tmax1 and Tmax2 only for BID dosing.
|
12.0 hours
Interval 6.0 to 14.0
|
6.00 hours
Interval 4.0 to 10.0
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax1 on Day 14 or 21
|
4.00 hours
Interval 2.0 to 8.0
|
4.00 hours
Interval 1.0 to 6.0
|
1.05 hours
Interval 1.0 to 6.0
|
1.54 hours
Interval 1.0 to 6.0
|
6.00 hours
Interval 1.0 to 6.0
|
6.00 hours
Interval 4.0 to 10.0
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax2 on Day 14 or 21
|
13.0 hours
Interval 12.0 to 14.0
|
13.0 hours
Interval 10.0 to 14.0
|
12.0 hours
Interval 12.0 to 12.0
|
12.0 hours
Interval 10.0 to 14.0
|
12.0 hours
Interval 12.0 to 14.0
|
14.0 hours
Interval 12.0 to 24.0
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
—
|
|
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
Tmax1 on Day 28
|
5.00 hours
Interval 4.0 to 8.0
|
3.00 hours
Interval 0.0 to 8.0
|
6.00 hours
Interval 2.0 to 8.0
|
4.00 hours
Interval 1.0 to 6.0
|
4.00 hours
Interval 2.0 to 8.0
|
6.00 hours
Interval 4.0 to 10.0
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
NA hours
Data was calculated as Tmax only for QD dosing.
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28Population: All participants randomized and treated who had at least 1 of the PK parameters of interest.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=10 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t½) of PF-06882961 on Day 28
|
5.100 hours
Standard Deviation 1.2186
|
5.067 hours
Standard Deviation 0.75593
|
4.681 hours
Standard Deviation 0.59504
|
6.203 hours
Standard Deviation 2.3505
|
8.090 hours
Standard Deviation 3.3234
|
6.730 hours
Standard Deviation 2.5056
|
5.773 hours
Standard Deviation 1.4876
|
4.954 hours
Standard Deviation 0.58819
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose on Day 28Population: All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.
Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=8 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=7 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=7 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
|
17.25 microgram
Geometric Coefficient of Variation 36
|
33.60 microgram
Geometric Coefficient of Variation 69
|
41.16 microgram
Geometric Coefficient of Variation 243
|
NA microgram
Geometric Coefficient of Variation NA
"NA" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
14.97 microgram
Geometric Coefficient of Variation 67
|
62.63 microgram
Geometric Coefficient of Variation 439
|
72.98 microgram
Geometric Coefficient of Variation 38
|
49.09 microgram
Geometric Coefficient of Variation 97
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose on Day 28Population: All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.
Percent of dose recovered in urine as unchanged drug. Ae24% = 100\* Ae24/Dose
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=8 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=7 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=7 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Ae24 (%) of PF-06882961 on Day 28
|
0.05747 Percentage
Geometric Coefficient of Variation 36
|
0.03360 Percentage
Geometric Coefficient of Variation 69
|
0.02942 Percentage
Geometric Coefficient of Variation 242
|
NA Percentage
Geometric Coefficient of Variation NA
"NA" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.07483 Percentage
Geometric Coefficient of Variation 67
|
0.02607 Percentage
Geometric Coefficient of Variation 439
|
0.03652 Percentage
Geometric Coefficient of Variation 38
|
0.04094 Percentage
Geometric Coefficient of Variation 97
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose on Day 28Population: All randomized participants who received at least 1 dose of PF-06882961 and who have at least 1 of the PK parameters of interest.
CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=10 Participants
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=8 Participants
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=7 Participants
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=7 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 Participants
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) of PF-06882961 on Day 28
|
0.3273 mL/min
Geometric Coefficient of Variation 18
|
0.3385 mL/min
Geometric Coefficient of Variation 18
|
0.3094 mL/min
Geometric Coefficient of Variation 70
|
NA mL/min
Geometric Coefficient of Variation NA
"NA" indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.5470 mL/min
Geometric Coefficient of Variation 26
|
0.2006 mL/min
Geometric Coefficient of Variation 228
|
0.2895 mL/min
Geometric Coefficient of Variation 21
|
0.3178 mL/min
Geometric Coefficient of Variation 73
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
PF-06882961 10mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06882961 15mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06882961 50mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
PF-06882961 70mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06882961 120mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06882961 120mg BID ST
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06882961 120mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06882961 200mg QD CR
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 participants at risk
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 participants at risk
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 participants at risk
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 participants at risk
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Placebo matched to PF-06882961 was administered orally QD or BID(dependent upon corresponding study treatment regimen) for a total of 28 days.
|
PF-06882961 10mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 5 mg BID from Day 1 to Day 14 followed by a dose of 10 mg BID from Day 15 to Day 28.
|
PF-06882961 15mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 15 mg BID for a total of 28 days.
|
PF-06882961 50mg BID
n=10 participants at risk
PF-06882961 tablet was administered orally at 50 mg BID for a total of 28 days.
|
PF-06882961 70mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 20 mg (Day 1-3), 40 mg (Day 4-6), 50 mg (Day 7-9) and 70 mg (Day 10-28) BID for a total of 28 days.
|
PF-06882961 120mg BID
n=9 participants at risk
PF-06882961 tablet was administered orally at 20 mg (Day 1-2), 40 mg (Day 3-4), 60 mg (Day 5-6), 80 mg (Day 7-9), 100 mg (Day 10-12) and 120 mg (Day 13-28) BID for a total of 28 days.
|
PF-06882961 120mg BID ST
n=9 participants at risk
PF-06882961 tablet was administered orally at 10 mg (Day 1-4), 20 mg (Day 5-8), 40 mg (Day 9-12), 60 mg (Day 13-16), 80 mg (Day 17-20), 100 mg (Day 21-24) and 120 mg (Day 25-28) BID for a total of 28 days.
|
PF-06882961 120mg QD
n=8 participants at risk
PF-06882961 tablet was administered orally at 10 mg (Day 1-2), 20 mg (Day 3-4), 30 mg (Day 5-6), 40 mg (Day 7-10), 60 mg (Day 11-14), 80 mg (Day 15-18), 100 mg (Day 19-22) and 120 mg (Day 23-28) QD for a total of 28 days.
|
PF-06882961 200mg QD CR
n=10 participants at risk
PF-06882961 CR tablet was administered orally at 50 mg (Day 1-7), 100 mg (Day 8-14), 150 mg (Day 15-21) and 200 mg (Day 22-28) QD for a total of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
32.0%
8/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
4/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Early satiety
|
8.0%
2/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
4.0%
1/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
3/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
2/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
6/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
5/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
3/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
3/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
44.4%
4/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
2/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.0%
4/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
44.4%
4/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
44.4%
4/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
77.8%
7/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
37.5%
3/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
—
0/0 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
—
0/0 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
1/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gingivitis ulcerative
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
70.0%
7/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
3/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
88.9%
8/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
9/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
87.5%
7/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
80.0%
8/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
77.8%
7/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
77.8%
7/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
37.5%
3/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious 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
|
8.0%
2/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
2/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
1/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
6/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
37.5%
3/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious 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%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious 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%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious 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%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious 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
|
8.0%
2/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/25 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • Baseline up to 35 days after last dose for a total of approximately 63 days
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 nonserious 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 Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER