Trial Outcomes & Findings for Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients (NCT NCT01723514)
NCT ID: NCT01723514
Last Updated: 2019-01-18
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
From first dose of study drug until a maximum of 168 days after last dose (225 days)
Results posted on
2019-01-18
Participant Flow
This study enrolled healthy participants (Part A) and participants with onset of migraines before the age of 50 years, with or without aura for at least 6 months and 3 migraine attacks per month in the last 3 months (Part B). The study was conducted at a single center in Belgium.
Healthy participants were randomized to 1 of 4 cohorts and migraine patients were randomized to 1 of 2 cohorts. Within each cohort participants were assigned to erenumab or placebo in a 3:1 ratio.
Participant milestones
| Measure |
Healthy: Placebo
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data are reported separately for each part of the study.
Baseline characteristics by cohort
| Measure |
Healthy: Placebo
n=8 Participants
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 Participants
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Healthy Participants
|
32.1 years
STANDARD_DEVIATION 13.0 • n=8 Participants • Data are reported separately for each part of the study.
|
26.3 years
STANDARD_DEVIATION 5.7 • n=6 Participants • Data are reported separately for each part of the study.
|
33.3 years
STANDARD_DEVIATION 14.1 • n=6 Participants • Data are reported separately for each part of the study.
|
29.8 years
STANDARD_DEVIATION 8.6 • n=6 Participants • Data are reported separately for each part of the study.
|
39.0 years
STANDARD_DEVIATION 13.8 • n=6 Participants • Data are reported separately for each part of the study.
|
—
|
—
|
—
|
32.1 years
STANDARD_DEVIATION 11.6 • n=32 Participants • Data are reported separately for each part of the study.
|
|
Age, Continuous
Migraine Participants
|
—
|
—
|
—
|
—
|
—
|
37.0 years
STANDARD_DEVIATION 11.9 • n=4 Participants • Data are reported separately for each part of the study.
|
31.7 years
STANDARD_DEVIATION 11.0 • n=6 Participants • Data are reported separately for each part of the study.
|
31.3 years
STANDARD_DEVIATION 12.6 • n=6 Participants • Data are reported separately for each part of the study.
|
32.9 years
STANDARD_DEVIATION 11.3 • n=16 Participants • Data are reported separately for each part of the study.
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
15 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
33 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
48 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until a maximum of 168 days after last dose (225 days)Population: All participants who received at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Outcome measures
| Measure |
Healthy: Placebo
n=8 Participants
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 Participants
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
Serious adverse event
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
TRAE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
TRAE leading to discontinuation from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until a maximum of 168 days after last dose (225 days)Population: All participants who received at least 1 dose of study drug.
The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.
Outcome measures
| Measure |
Healthy: Placebo
n=8 Participants
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 Participants
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until a maximum of 168 days after last dose (225 days)Population: All participants who received at least 1 dose of study drug.
Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
Outcome measures
| Measure |
Healthy: Placebo
n=8 Participants
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 Participants
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-erenumab Antibodies
Binding antibodies
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Anti-erenumab Antibodies
Neutralizing antibodies
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)Population: All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Healthy: Placebo
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Erenumab
Day 1
|
—
|
2.15 μg/mL
Standard Deviation 0.914
|
6.26 μg/mL
Standard Deviation 2.55
|
13.8 μg/mL
Standard Deviation 4.00
|
24.9 μg/mL
Standard Deviation 4.90
|
—
|
1.76 μg/mL
Standard Deviation 0.741
|
11.0 μg/mL
Standard Deviation 3.85
|
|
Maximum Observed Serum Concentration (Cmax) of Erenumab
Day 57
|
—
|
2.60 μg/mL
Standard Deviation 0.952
|
9.63 μg/mL
Standard Deviation 3.60
|
23.7 μg/mL
Standard Deviation 7.89
|
36.3 μg/mL
Standard Deviation 6.18
|
—
|
2.00 μg/mL
Standard Deviation 0.552
|
18.4 μg/mL
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)Population: All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Healthy: Placebo
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Erenumab
Day 1
|
—
|
4.0 days
Interval 3.0 to 6.9
|
4.0 days
Interval 3.0 to 11.0
|
5.9 days
Interval 3.1 to 13.0
|
6.9 days
Interval 3.0 to 6.9
|
—
|
6.9 days
Interval 4.0 to 7.0
|
11 days
Interval 4.0 to 13.0
|
|
Time to Maximum Observed Concentration (Tmax) of Erenumab
Day 57
|
—
|
6.9 days
Interval 5.9 to 7.9
|
7.9 days
Interval 6.9 to 14.0
|
6.9 days
Interval 6.9 to 8.0
|
6.9 days
Interval 6.9 to 8.0
|
—
|
6.9 days
Interval 6.9 to 7.9
|
6.9 days
Interval 6.9 to 7.0
|
SECONDARY outcome
Timeframe: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)Population: All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Healthy: Placebo
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)
Day 57
|
—
|
49.5 day*μg/mL
Standard Deviation 20.1
|
216 day*μg/mL
Standard Deviation 82.7
|
476 day*μg/mL
Standard Deviation 161
|
760 day*μg/mL
Standard Deviation 143
|
—
|
37.9 day*μg/mL
Standard Deviation 12.5
|
417 day*μg/mL
Standard Deviation 117
|
|
Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)
Day 1
|
—
|
34.7 day*μg/mL
Standard Deviation 13.1
|
124 day*μg/mL
Standard Deviation 49.2
|
281 day*μg/mL
Standard Deviation 89.1
|
486 day*μg/mL
Standard Deviation 57.8
|
—
|
28.7 day*μg/mL
Standard Deviation 11.0
|
244 day*μg/mL
Standard Deviation 86.2
|
SECONDARY outcome
Timeframe: Day 57 (assessed from predose to day 225))Population: All participants who received erenumab and for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Healthy: Placebo
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 Participants
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
|
—
|
59.3 day*μg/mL
Standard Deviation 27.8
|
342 day*μg/mL
Standard Deviation 144
|
848 day*μg/mL
Standard Deviation 376
|
1410 day*μg/mL
Standard Deviation 332
|
—
|
45.0 day*μg/mL
Standard Deviation 15.7
|
773 day*μg/mL
Standard Deviation 214
|
SECONDARY outcome
Timeframe: Baseline, Days 8, 57, 85, 113, 169 and 197Population: All participants for whom at least 1 postdose capsaicin response measure was recorded. Measurement and analysis of dermal blood flow were not performed in the 280/210 cohort.
Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites. Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow. According to the protocol, not all cohorts had dermal blood flow measurements at all time points.
Outcome measures
| Measure |
Healthy: Placebo
n=6 Participants
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 Participants
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 Participants
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 Participants
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 Participants
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 Participants
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 Participants
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Baseline
|
9.24 ratio
Standard Error 1.20
|
9.28 ratio
Standard Error 1.21
|
8.92 ratio
Standard Error 1.20
|
8.90 ratio
Standard Error 1.22
|
—
|
13.27 ratio
Standard Error 1.37
|
11.08 ratio
Standard Error 1.29
|
11.70 ratio
Standard Error 1.28
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 8
|
8.53 ratio
Standard Error 1.20
|
1.76 ratio
Standard Error 1.21
|
2.46 ratio
Standard Error 1.20
|
1.75 ratio
Standard Error 1.22
|
—
|
13.20 ratio
Standard Error 1.37
|
2.64 ratio
Standard Error 1.29
|
1.64 ratio
Standard Error 1.28
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 57
|
6.75 ratio
Standard Error 1.20
|
1.87 ratio
Standard Error 1.21
|
1.82 ratio
Standard Error 1.20
|
1.90 ratio
Standard Error 1.22
|
—
|
12.30 ratio
Standard Error 1.37
|
2.48 ratio
Standard Error 1.29
|
2.01 ratio
Standard Error 1.28
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 85
|
8.61 ratio
Standard Error 1.20
|
2.71 ratio
Standard Error 1.21
|
1.63 ratio
Standard Error 1.20
|
1.80 ratio
Standard Error 1.22
|
—
|
13.33 ratio
Standard Error 1.37
|
2.40 ratio
Standard Error 1.29
|
2.08 ratio
Standard Error 1.28
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 113
|
11.11 ratio
Standard Error 1.33
|
7.48 ratio
Standard Error 1.21
|
—
|
—
|
—
|
3.50 ratio
Standard Error 1.51
|
5.00 ratio
Standard Error 1.29
|
—
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 169
|
9.72 ratio
Standard Error 1.24
|
—
|
10.06 ratio
Standard Error 1.20
|
5.78 ratio
Standard Error 1.22
|
—
|
14.78 ratio
Standard Error 1.51
|
—
|
4.64 ratio
Standard Error 1.28
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 197
|
7.20 ratio
Standard Error 1.33
|
—
|
—
|
8.16 ratio
Standard Error 1.22
|
—
|
18.52 ratio
Standard Error 1.51
|
—
|
8.46 ratio
Standard Error 1.28
|
Adverse Events
Healthy: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy: Erenumab 21 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy: Erenumab 70 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy: Erenumab 140 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy: Erenumab 280/210 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Migraine: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Migraine: Erenumab 21 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Migraine: Erenumab 140 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy: Placebo
n=8 participants at risk
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 participants at risk
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 participants at risk
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 participants at risk
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 participants at risk
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 participants at risk
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 participants at risk
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 participants at risk
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Healthy: Placebo
n=8 participants at risk
Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.
|
Healthy: Erenumab 21 mg
n=6 participants at risk
Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 70 mg
n=6 participants at risk
Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 140 mg
n=6 participants at risk
Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Healthy: Erenumab 280/210 mg
n=6 participants at risk
Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.
|
Migraine: Placebo
n=4 participants at risk
Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 21 mg
n=6 participants at risk
Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
Migraine: Erenumab 140 mg
n=6 participants at risk
Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
25.0%
2/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site pain
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Local swelling
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose increased
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood immunoglobulin E increased
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
2/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
1/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/4 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER