Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B (NCT NCT03038113)
NCT ID: NCT03038113
Last Updated: 2020-12-24
Results Overview
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs of Special Interest were defined as: i.) elevated ALT/AST in combination with elevated bilirubin/clinical jaundice, ii.) suspected transmission of infectious agent by the study drug, iii.) severe injection site reactions, iv.) ALT elevation ≥10x ULN, v.) creatinine elevation ≥1.5x ULN or ≥50% from baseline.
COMPLETED
PHASE1
119 participants
Up to day 113
2020-12-24
Participant Flow
Participant milestones
| Measure |
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
12
|
6
|
7
|
6
|
14
|
7
|
4
|
15
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
8
|
8
|
8
|
11
|
6
|
7
|
6
|
14
|
7
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
n=6 Participants
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
n=7 Participants
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
n=6 Participants
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
n=14 Participants
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
n=7 Participants
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
n=4 Participants
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
n=15 Participants
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.8 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
29.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
34.0 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
30.4 Years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
24.8 Years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
23.4 Years
STANDARD_DEVIATION 3.5 • n=10 Participants
|
31.6 Years
STANDARD_DEVIATION 9.0 • n=115 Participants
|
42.0 Years
STANDARD_DEVIATION 5.3 • n=6 Participants
|
42.7 Years
STANDARD_DEVIATION 11.1 • n=6 Participants
|
47.8 Years
STANDARD_DEVIATION 7.2 • n=64 Participants
|
46.1 Years
STANDARD_DEVIATION 12.1 • n=17 Participants
|
44.9 Years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
48.5 Years
STANDARD_DEVIATION 6.9 • n=22 Participants
|
44.7 Years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
37.1 Years
STANDARD_DEVIATION 12.6 • n=16 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
12 Participants
n=17 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
14 Participants
n=8 Participants
|
111 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
14 Participants
n=17 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
15 Participants
n=8 Participants
|
114 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
14 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
15 Participants
n=8 Participants
|
68 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
38 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Up to day 113Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs of Special Interest were defined as: i.) elevated ALT/AST in combination with elevated bilirubin/clinical jaundice, ii.) suspected transmission of infectious agent by the study drug, iii.) severe injection site reactions, iv.) ALT elevation ≥10x ULN, v.) creatinine elevation ≥1.5x ULN or ≥50% from baseline.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
n=6 Participants
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
n=7 Participants
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
n=6 Participants
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
n=14 Participants
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
n=7 Participants
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
n=4 Participants
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
n=15 Participants
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
AEs
|
75.0 Percentage of Participants
|
87.5 Percentage of Participants
|
37.5 Percentage of Participants
|
75.0 Percentage of Participants
|
87.5 Percentage of Participants
|
50.0 Percentage of Participants
|
58.3 Percentage of Participants
|
33.3 Percentage of Participants
|
85.7 Percentage of Participants
|
66.7 Percentage of Participants
|
71.4 Percentage of Participants
|
57.1 Percentage of Participants
|
75.0 Percentage of Participants
|
53.3 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
AEs of Special Interest
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Screening, Days -1, 2, 8, 15, 29, 85Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
SGOT/AST - High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
Chloride - Low
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
HDL Cholesterol - Low
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
Triglycerides - High
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=15 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
SGOT/AST - High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Glucose, Fasting - High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
SGPT/ALT - High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Bicorbonate HCO3 - Low
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Activated Partial Thromboplastin Time - High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Triglycerides - High
|
100 Percentage of Participants
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF \> 500 msec, or \> 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Baseline
|
12.5 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
37.5 Percentage of Participants
|
25.0 Percentage of Participants
|
16.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Day 1 - 1h
|
37.5 Percentage of Participants
|
50.0 Percentage of Participants
|
12.5 Percentage of Participants
|
25.0 Percentage of Participants
|
37.5 Percentage of Participants
|
25.0 Percentage of Participants
|
41.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Day 1 - 4h
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
12.5 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
12.5 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Day 1 - 8h
|
37.5 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
12.5 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
58.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Day 1 - 12h
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
37.5 Percentage of Participants
|
12.5 Percentage of Participants
|
58.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Day 2 - 24h
|
37.5 Percentage of Participants
|
50.0 Percentage of Participants
|
12.5 Percentage of Participants
|
12.5 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Day 8 - 168h
|
12.5 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
37.5 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
41.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Follow-up Day 15
|
12.5 Percentage of Participants
|
12.5 Percentage of Participants
|
12.5 Percentage of Participants
|
25.0 Percentage of Participants
|
12.5 Percentage of Participants
|
12.5 Percentage of Participants
|
16.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Follow-up Day 29
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
36.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Extended Follow-Up
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
28.6 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF \> 500 msec, or \> 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=15 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 2 - 24h
|
33.3 Percentage of Participants
|
28.6 Percentage of Participants
|
50.0 Percentage of Participants
|
57.1 Percentage of Participants
|
57.1 Percentage of Participants
|
50.0 Percentage of Participants
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 29 - 4h
|
50.0 Percentage of Participants
|
33.3 Percentage of Participants
|
16.7 Percentage of Participants
|
57.1 Percentage of Participants
|
66.7 Percentage of Participants
|
—
|
25.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 30 - 24h
|
66.7 Percentage of Participants
|
16.7 Percentage of Participants
|
100 Percentage of Participants
|
50.0 Percentage of Participants
|
66.7 Percentage of Participants
|
—
|
41.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Baseline
|
33.3 Percentage of Participants
|
14.3 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
50.0 Percentage of Participants
|
46.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 1 - 1h
|
66.7 Percentage of Participants
|
42.9 Percentage of Participants
|
50.0 Percentage of Participants
|
57.1 Percentage of Participants
|
85.7 Percentage of Participants
|
75.0 Percentage of Participants
|
40.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 1 - 4h
|
33.3 Percentage of Participants
|
42.9 Percentage of Participants
|
66.7 Percentage of Participants
|
64.3 Percentage of Participants
|
57.1 Percentage of Participants
|
50.0 Percentage of Participants
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 1 - 8h
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
25.0 Percentage of Participants
|
26.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 8
|
66.7 Percentage of Participants
|
57.1 Percentage of Participants
|
50.0 Percentage of Participants
|
57.1 Percentage of Participants
|
66.7 Percentage of Participants
|
25.0 Percentage of Participants
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 15
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
83.3 Percentage of Participants
|
50.0 Percentage of Participants
|
71.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 22
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
—
|
75.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 22 - 1h
|
—
|
—
|
—
|
—
|
—
|
75.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 22 - 8h
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 23 - 24h
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 29
|
66.7 Percentage of Participants
|
50.0 Percentage of Participants
|
83.3 Percentage of Participants
|
50.0 Percentage of Participants
|
83.3 Percentage of Participants
|
—
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 29 - 1h
|
83.3 Percentage of Participants
|
16.7 Percentage of Participants
|
50.0 Percentage of Participants
|
64.3 Percentage of Participants
|
83.3 Percentage of Participants
|
—
|
58.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Day 29 - 8h
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
66.7 Percentage of Participants
|
64.3 Percentage of Participants
|
66.7 Percentage of Participants
|
—
|
16.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 36
|
—
|
—
|
—
|
—
|
—
|
75.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 43
|
83.3 Percentage of Participants
|
14.3 Percentage of Participants
|
16.7 Percentage of Participants
|
57.1 Percentage of Participants
|
57.1 Percentage of Participants
|
—
|
38.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 50
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 57
|
66.7 Percentage of Participants
|
14.3 Percentage of Participants
|
66.7 Percentage of Participants
|
57.1 Percentage of Participants
|
71.4 Percentage of Participants
|
—
|
53.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 78
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 85
|
33.3 Percentage of Participants
|
14.3 Percentage of Participants
|
66.7 Percentage of Participants
|
50.0 Percentage of Participants
|
57.1 Percentage of Participants
|
—
|
38.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 106
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Follow-up Day 113
|
66.7 Percentage of Participants
|
14.3 Percentage of Participants
|
50.0 Percentage of Participants
|
42.9 Percentage of Participants
|
71.4 Percentage of Participants
|
—
|
46.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Baseline
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Day 1 - 1h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Day 1 - 4h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Day 1 - 8h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Day 1 - 12h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Day 2 - 24h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Day 8 - 168h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Follow-up Day 15
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Follow-up Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Extended Follow-Up
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Day 2 - 24h
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Day 8 - 168h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Follow-up Day 15
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Follow-up Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Extended Follow-Up
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Baseline
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Day 1 - 1h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Day 1 - 4h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Day 1 - 8h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Day 1 - 12h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=15 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 2 - 24h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 8
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 15
|
—
|
—
|
—
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 22
|
—
|
—
|
—
|
7.1 Percentage of Participants
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 22 - 1h
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 22 - 8h
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 23 - 24h
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 29 - 1h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 29 - 4h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Baseline
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 1 - 1h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 1 - 4h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 1 - 8h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 29 - 8h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Day 30 - 24h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 36
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 43
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 50
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 57
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 78
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 85
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 106
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Follow-up Day 113
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=15 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 8
|
16.7 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 78
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 85
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
7.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 106
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 113
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
14.3 Percentage of Participants
|
—
|
15.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Baseline
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 1 - 1h
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 1 - 4h
|
16.7 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 1 - 8h
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 2 - 24h
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 15
|
—
|
—
|
—
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 22
|
—
|
—
|
—
|
7.1 Percentage of Participants
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 22 - 1h
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 22 - 8h
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 23 - 24h
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 29
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 29 - 1h
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 29 - 4h
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 29 - 8h
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Day 30 - 24h
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 36
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 43
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 50
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Follow-up Day 57
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
7.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113Population: Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=15 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 30 - 24h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Baseline
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 1 - 1h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 1 - 4h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 1 - 8h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 2 - 24h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 8
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 15
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 22
|
—
|
—
|
—
|
7.1 Percentage of Participants
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 22 - 1h
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 22 - 8h
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 23 - 24h
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 29 - 1h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 29 - 4h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
8.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Day 29 - 8h
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 36
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 43
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 50
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 57
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 78
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 85
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
33.3 Percentage of Participants
|
7.1 Percentage of Participants
|
14.3 Percentage of Participants
|
—
|
7.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 106
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Follow-up Day 113
|
0 Percentage of Participants
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1
|
7.78 nmol/L
Geometric Coefficient of Variation 40.2
|
19.53 nmol/L
Geometric Coefficient of Variation 28.1
|
41.69 nmol/L
Geometric Coefficient of Variation 30.8
|
103.68 nmol/L
Geometric Coefficient of Variation 34.0
|
312.53 nmol/L
Geometric Coefficient of Variation 22.2
|
153.53 nmol/L
Geometric Coefficient of Variation 25.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax After Multiple Ascending Doses - Part 2
First Dose
|
21.17 mg/kg
Geometric Coefficient of Variation 46.4
|
72.44 mg/kg
Geometric Coefficient of Variation 57.8
|
169.56 mg/kg
Geometric Coefficient of Variation 43.9
|
158.61 mg/kg
Geometric Coefficient of Variation 37.9
|
218.05 mg/kg
Geometric Coefficient of Variation 64.4
|
232.54 mg/kg
Geometric Coefficient of Variation 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax After Multiple Ascending Doses - Part 2
Last Dose
|
18.56 mg/kg
Geometric Coefficient of Variation 69.1
|
82.11 mg/kg
Geometric Coefficient of Variation 37.6
|
194.72 mg/kg
Geometric Coefficient of Variation 15.8
|
164.83 mg/kg
Geometric Coefficient of Variation 65.0
|
190.83 mg/kg
Geometric Coefficient of Variation 35.6
|
250.72 mg/kg
Geometric Coefficient of Variation 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1
|
1.75 Hours (h)
Interval 1.0 to 3.0
|
2.00 Hours (h)
Interval 1.5 to 2.0
|
3.00 Hours (h)
Interval 1.5 to 6.0
|
2.00 Hours (h)
Interval 2.0 to 6.0
|
3.00 Hours (h)
Interval 2.0 to 6.0
|
2.00 Hours (h)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax After Multiple Ascending Doses - Part 2
First Dose
|
2.98 Hours (h)
Interval 0.5 to 7.9
|
2.00 Hours (h)
Interval 2.0 to 4.0
|
2.00 Hours (h)
Interval 1.9 to 8.0
|
4.00 Hours (h)
Interval 1.9 to 6.0
|
3.98 Hours (h)
Interval 1.9 to 5.9
|
2.00 Hours (h)
Interval 1.9 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax After Multiple Ascending Doses - Part 2
Last Dose
|
3.04 Hours (h)
Interval 2.0 to 7.7
|
3.00 Hours (h)
Interval 2.0 to 6.0
|
4.00 Hours (h)
Interval 2.0 to 4.1
|
1.97 Hours (h)
Interval 1.9 to 7.8
|
2.94 Hours (h)
Interval 1.9 to 5.7
|
2.95 Hours (h)
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
AUC0-inf was calculated based on non-compartmental analysis.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1
|
39.21 h*nmol/L
Geometric Coefficient of Variation 14.0
|
92.72 h*nmol/L
Geometric Coefficient of Variation 14.1
|
308.48 h*nmol/L
Geometric Coefficient of Variation 13.2
|
792.36 h*nmol/L
Geometric Coefficient of Variation 19.1
|
2478.56 h*nmol/L
Geometric Coefficient of Variation 8.7
|
1257.23 h*nmol/L
Geometric Coefficient of Variation 19.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1,22,29Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
AUC0-inf was calculated based on non-compartmental analysis.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf After Multiple Ascending Doses - Part 2
Day 1
|
175.30 h*nmol/L
Geometric Coefficient of Variation 6.9
|
567.07 h*nmol/L
Geometric Coefficient of Variation 41.5
|
1606.49 h*nmol/L
Geometric Coefficient of Variation 26.4
|
1434.39 h*nmol/L
Geometric Coefficient of Variation 13.6
|
1857.98 h*nmol/L
Geometric Coefficient of Variation 41.2
|
2371.66 h*nmol/L
Geometric Coefficient of Variation 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-inf After Multiple Ascending Doses - Part 2
Day 22
|
—
|
—
|
—
|
—
|
—
|
2199.57 h*nmol/L
Geometric Coefficient of Variation 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-inf After Multiple Ascending Doses - Part 2
Day 29
|
180.34 h*nmol/L
Geometric Coefficient of Variation 13.3
|
680.80 h*nmol/L
Geometric Coefficient of Variation 8.8
|
1636.76 h*nmol/L
Geometric Coefficient of Variation 11.0
|
1475.19 h*nmol/L
Geometric Coefficient of Variation 30.3
|
1541.85 h*nmol/L
Geometric Coefficient of Variation 26.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
AUC0-last was calculated based on non-compartmental analysis.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=7 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1
|
39.10 (hr*nmol/L)
Geometric Coefficient of Variation 14.0
|
92.62 (hr*nmol/L)
Geometric Coefficient of Variation 14.1
|
310.69 (hr*nmol/L)
Geometric Coefficient of Variation 12.9
|
789.27 (hr*nmol/L)
Geometric Coefficient of Variation 19.1
|
2448.99 (hr*nmol/L)
Geometric Coefficient of Variation 8.1
|
1253.26 (hr*nmol/L)
Geometric Coefficient of Variation 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1,22,29Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
AUC0-last was calculated based on non-compartmental analysis.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-last After Multiple Ascending Doses - Part 2
Day 1
|
147.30 hr*nmol/L
Geometric Coefficient of Variation 28.8
|
555.16 hr*nmol/L
Geometric Coefficient of Variation 34.8
|
1603.81 hr*nmol/L
Geometric Coefficient of Variation 26.4
|
1458.57 hr*nmol/L
Geometric Coefficient of Variation 12.9
|
1929.56 hr*nmol/L
Geometric Coefficient of Variation 49.9
|
2279.78 hr*nmol/L
Geometric Coefficient of Variation 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-last After Multiple Ascending Doses - Part 2
Day 22
|
—
|
—
|
—
|
—
|
—
|
2195.18 hr*nmol/L
Geometric Coefficient of Variation 16.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-last After Multiple Ascending Doses - Part 2
Day 29
|
141.35 hr*nmol/L
Geometric Coefficient of Variation 52.6
|
662.95 hr*nmol/L
Geometric Coefficient of Variation 20.5
|
1633.64 hr*nmol/L
Geometric Coefficient of Variation 11.0
|
1470.64 hr*nmol/L
Geometric Coefficient of Variation 30.5
|
1539.73 hr*nmol/L
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
T1/2 was calculated based on non-compartmental analysis.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1
|
3.77 Hours (h)
Geometric Coefficient of Variation 65.4
|
3.99 Hours (h)
Geometric Coefficient of Variation 38.3
|
44.32 Hours (h)
Geometric Coefficient of Variation 170.4
|
97.06 Hours (h)
Geometric Coefficient of Variation 35.9
|
115.24 Hours (h)
Geometric Coefficient of Variation 60.4
|
85.70 Hours (h)
Geometric Coefficient of Variation 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
T1/2 was calculated based on non-compartmental analysis.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
First Dose
|
2.99 Hours (h)
Geometric Coefficient of Variation 13.1
|
18.81 Hours (h)
Geometric Coefficient of Variation 32.0
|
88.59 Hours (h)
Geometric Coefficient of Variation 94.1
|
NA Hours (h)
Geometric Coefficient of Variation NA
Insufficient data to estimate parameter.
|
37.96 Hours (h)
Geometric Coefficient of Variation 62.1
|
15.09 Hours (h)
Geometric Coefficient of Variation 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
Last Dose
|
3.86 Hours (h)
Geometric Coefficient of Variation 107.8
|
NA Hours (h)
Geometric Coefficient of Variation NA
Insufficient data to estimate parameter.
|
119.45 Hours (h)
Geometric Coefficient of Variation 58.8
|
172.20 Hours (h)
Geometric Coefficient of Variation 26.7
|
62.08 Hours (h)
Geometric Coefficient of Variation 91.8
|
152.79 Hours (h)
Geometric Coefficient of Variation 28.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Apparent oral clearance was calculated from Dose/AUCinf.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) After Single Ascending Doses - Part 1
|
26.68 L/h
Geometric Coefficient of Variation 21.3
|
35.97 L/h
Geometric Coefficient of Variation 24.7
|
37.36 L/h
Geometric Coefficient of Variation 29.9
|
26.9 L/h
Geometric Coefficient of Variation 20.8
|
16.15 L/h
Geometric Coefficient of Variation 18.4
|
23.46 L/h
Geometric Coefficient of Variation 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Apparent oral clearance was calculated from Dose/AUCinf.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) After Multiple Ascending Doses - Part 2
|
31.12 L/h
Geometric Coefficient of Variation 10.2
|
NA L/h
Geometric Coefficient of Variation NA
Insufficient data to estimate parameter.
|
18.12 L/h
Geometric Coefficient of Variation 27.2
|
21.76 L/h
Geometric Coefficient of Variation 42.0
|
19.37 L/h
Geometric Coefficient of Variation 43.5
|
18.75 L/h
Geometric Coefficient of Variation 34.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-8Vss was calculated from dose/AUCinf
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vss) After Single Ascending Doses - Part 1
|
145.22 Liters (L)
Geometric Coefficient of Variation 61.2
|
206.96 Liters (L)
Geometric Coefficient of Variation 35.2
|
2389.08 Liters (L)
Geometric Coefficient of Variation 228.8
|
3767.16 Liters (L)
Geometric Coefficient of Variation 34.4
|
2684.87 Liters (L)
Geometric Coefficient of Variation 56.8
|
2900.19 Liters (L)
Geometric Coefficient of Variation 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Population: The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Vss was calculated from dose/AUCinf
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2
|
173.27 Liters (L)
Geometric Coefficient of Variation 119.8
|
NA Liters (L)
Geometric Coefficient of Variation NA
Insufficient data to estimate parameter.
|
3122.3 Liters (L)
Geometric Coefficient of Variation 46.8
|
5405.97 Liters (L)
Geometric Coefficient of Variation 53.8
|
1734.46 Liters (L)
Geometric Coefficient of Variation 86.9
|
4131.91 Liters (L)
Geometric Coefficient of Variation 22.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours 0-4, 0-8, 0-12, and 0-24Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Accumulation Interval 0-12 (h)
|
10399.04 pmol
Geometric Coefficient of Variation 40.7
|
28335.16 pmol
Geometric Coefficient of Variation 27.6
|
143182.68 pmol
Geometric Coefficient of Variation 42.8
|
249381.19 pmol
Geometric Coefficient of Variation 72.6
|
1148178.69 pmol
Geometric Coefficient of Variation 38.2
|
592833.26 pmol
Geometric Coefficient of Variation 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Accumulation Interval 0-4 (h)
|
6180.14 pmol
Geometric Coefficient of Variation 85.0
|
17111.86 pmol
Geometric Coefficient of Variation 29.4
|
50248.03 pmol
Geometric Coefficient of Variation 97.0
|
108870.36 pmol
Geometric Coefficient of Variation 95.4
|
317169.45 pmol
Geometric Coefficient of Variation 62.1
|
206781.39 pmol
Geometric Coefficient of Variation 34.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Accumulation Interval 0-8 (h)
|
9028.41 pmol
Geometric Coefficient of Variation 50.4
|
25608.73 pmol
Geometric Coefficient of Variation 25.2
|
117472.78 pmol
Geometric Coefficient of Variation 52.5
|
202181.27 pmol
Geometric Coefficient of Variation 80.6
|
930967.60 pmol
Geometric Coefficient of Variation 42.2
|
458520.65 pmol
Geometric Coefficient of Variation 21.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Accumulation Interval 0-24 (h)
|
11043.57 pmol
Geometric Coefficient of Variation 38.9
|
29221.86 pmol
Geometric Coefficient of Variation 28.6
|
155256.07 pmol
Geometric Coefficient of Variation 38.9
|
275688.93 pmol
Geometric Coefficient of Variation 68.3
|
1235241.74 pmol
Geometric Coefficient of Variation 33.9
|
647368.11 pmol
Geometric Coefficient of Variation 12.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=7 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=14 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2
|
48.45 nmol
Geometric Coefficient of Variation 22.48
|
183.38 nmol
Geometric Coefficient of Variation 67.53
|
587.05 nmol
Geometric Coefficient of Variation 294.65
|
790.51 nmol
Geometric Coefficient of Variation 402.06
|
615.33 nmol
Geometric Coefficient of Variation 432.78
|
1146.02 nmol
Geometric Coefficient of Variation 177.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1-113Population: Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=15 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
Baseline value
|
3.39 IU/mL
Standard Deviation 0.360
|
3.37 IU/mL
Standard Deviation 0.272
|
3.37 IU/mL
Standard Deviation 0.134
|
3.68 IU/mL
Standard Deviation 0.381
|
3.76 IU/mL
Standard Deviation 0.285
|
3.69 IU/mL
Standard Deviation 0.274
|
3.55 IU/mL
Standard Deviation 0.421
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
Final change from baseline
|
-0.04 IU/mL
Standard Deviation 0.057
|
-0.05 IU/mL
Standard Deviation 0.072
|
-0.03 IU/mL
Standard Deviation 0.053
|
-0.09 IU/mL
Standard Deviation 0.090
|
-0.02 IU/mL
Standard Deviation 0.070
|
-0.16 IU/mL
Standard Deviation 0.088
|
-0.01 IU/mL
Standard Deviation 0.046
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 113Population: Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=6 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=6 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=13 Participants
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2
|
-0.105 IU/mL
Standard Deviation 0.0325
|
-0.360 IU/mL
Standard Deviation 0.3752
|
-0.279 IU/mL
Standard Deviation 0.0988
|
-0.495 IU/mL
Standard Deviation 0.2093
|
-0.394 IU/mL
Standard Deviation 0.1586
|
-0.336 IU/mL
Standard Deviation 0.1685
|
-0.101 IU/mL
Standard Deviation 0.0714
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 113Population: Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Outcome measures
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=7 Participants
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=6 Participants
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=14 Participants
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=7 Participants
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=4 Participants
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2
|
49.5 Days
Interval 35.0 to 113.0
|
43.0 Days
Interval 36.0 to 43.0
|
43.0 Days
Interval 36.0 to 85.0
|
43.0 Days
Interval 29.0 to 113.0
|
39.5 Days
Interval 36.0 to 85.0
|
61.0 Days
Interval 29.0 to 79.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 - RO7062931 0.1 mg/kg
Part 1 - RO7062931 0.3 mg/kg
Part 1 - RO7062931 1.0 mg/kg
Part 1 - RO7062931 2.0 mg/kg
Part 1 - RO7062931 3.0 mg/kg
Part 1 - RO7062931 4.0 mg/kg
Part 1 - Placebo
Part 2a - RO7062931 0.5 mg/kg Q1M
Part 2a - RO7062931 1.5 mg/kg Q1M
Part 2a - RO7062931 3.0 mg/kg Q1M
Part 2b - RO7062931 3.0 mg/kg QW
Part 2b - RO7062931 3.0 mg/kg Q2W
Part 2b - RO7062931 4.0 mg/kg QW
Part 2 - Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 - RO7062931 0.1 mg/kg
n=8 participants at risk
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
|
Part 1 - RO7062931 0.3 mg/kg
n=8 participants at risk
Participants received a single SC injection of 0.3 mg/kg RO7062931.
|
Part 1 - RO7062931 1.0 mg/kg
n=8 participants at risk
Participants received a single SC injection of 1.0 mg/kg RO7062931.
|
Part 1 - RO7062931 2.0 mg/kg
n=8 participants at risk
Participants received a single SC injection of 2.0 mg/kg RO7062931.
|
Part 1 - RO7062931 3.0 mg/kg
n=8 participants at risk
Participants received a single SC injection of 3.0 mg/kg RO7062931.
|
Part 1 - RO7062931 4.0 mg/kg
n=8 participants at risk
Participants received a single SC injection of 4.0 mg/kg RO7062931.
|
Part 1 - Placebo
n=12 participants at risk
Participants received a single SC injection of placebo matched to RO7062931.
|
Part 2a - RO7062931 0.5 mg/kg Q1M
n=6 participants at risk
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
|
Part 2a - RO7062931 1.5 mg/kg Q1M
n=7 participants at risk
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
|
Part 2a - RO7062931 3.0 mg/kg Q1M
n=6 participants at risk
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg QW
n=14 participants at risk
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 3.0 mg/kg Q2W
n=7 participants at risk
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
|
Part 2b - RO7062931 4.0 mg/kg QW
n=4 participants at risk
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
|
Part 2 - Placebo
n=15 participants at risk
Participants received SC placebo matched to RO7062931 over a 4-week period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
25.0%
1/4 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
25.0%
1/4 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Catheter site bruise
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Catheter site thrombosis
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Feeling hot
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
21.4%
3/14 • Number of events 3 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
28.6%
2/7 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
50.0%
2/4 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
13.3%
2/15 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
50.0%
4/8 • Number of events 4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
50.0%
4/8 • Number of events 7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
2/14 • Number of events 3 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
28.6%
2/7 • Number of events 3 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
25.0%
1/4 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Thirst
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Vessel puncture site bruise
|
25.0%
2/8 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Tonsillitis
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
2/8 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
13.3%
2/15 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Clavicle feacture
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
25.0%
2/8 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
2/8 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
13.3%
2/15 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Dizziness postural
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
25.0%
2/8 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
20.0%
3/15 • Number of events 3 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Nervous system disorders
Sensory disturbance
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
8.3%
1/12 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
2/12 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
12.5%
1/8 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 2 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
14.3%
1/7 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
16.7%
1/6 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
7.1%
1/14 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/15 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/8 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/12 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/6 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/14 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/7 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
0.00%
0/4 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
6.7%
1/15 • Number of events 1 • Approximately 32 months
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER