Trial Outcomes & Findings for Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients (NCT NCT01688739)
NCT ID: NCT01688739
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
61 participants
Primary outcome timeframe
From the initial dose of study drug up to 155 days.
Results posted on
2019-01-18
Participant Flow
This study was conducted at a single center in Belgium from March 2012 to March 2013. The study enrolled healthy participants (Part 1) and participants who had migraines for at least 6 months and at least 3 migraine attacks per month in the last 3 months (Part 2).
Healthy participants were randomized in a 3:1 ratio to erenumab or placebo within each dose cohort. Migraine participants were randomized in a 1:1 ratio to erenumab or placebo.
Participant milestones
| Measure |
Healthy: Placebo
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
Received Study Drug
|
12
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
12
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy: Placebo
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Administrative Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Data are reported separately for each part of the study.
Baseline characteristics by cohort
| Measure |
Healthy: Placebo
n=12 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
n=6 Participants
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
n=6 Participants
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Healthy Participants
|
28.6 years
STANDARD_DEVIATION 6.1 • n=12 Participants • Data are reported separately for each part of the study.
|
22.0 years
STANDARD_DEVIATION 1.7 • n=3 Participants • Data are reported separately for each part of the study.
|
26.0 years
STANDARD_DEVIATION 7.9 • n=3 Participants • Data are reported separately for each part of the study.
|
25.7 years
STANDARD_DEVIATION 6.9 • n=6 Participants • Data are reported separately for each part of the study.
|
27.5 years
STANDARD_DEVIATION 6.6 • n=6 Participants • Data are reported separately for each part of the study.
|
28.0 years
STANDARD_DEVIATION 8.5 • n=6 Participants • Data are reported separately for each part of the study.
|
31.0 years
STANDARD_DEVIATION 8.1 • n=6 Participants • Data are reported separately for each part of the study.
|
26.2 years
STANDARD_DEVIATION 7.0 • n=6 Participants • Data are reported separately for each part of the study.
|
—
|
—
|
27.4 years
STANDARD_DEVIATION 6.8 • n=48 Participants • Data are reported separately for each part of the study.
|
|
Age, Continuous
Migraine Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28.5 years
STANDARD_DEVIATION 12.6 • n=6 Participants • Data are reported separately for each part of the study.
|
23.8 years
STANDARD_DEVIATION 5.4 • n=6 Participants • Data are reported separately for each part of the study.
|
26.2 years
STANDARD_DEVIATION 9.6 • n=12 Participants • Data are reported separately for each part of the study.
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
51 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
59 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=12 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
59 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: From the initial dose of study drug up to 155 days.Population: All participants who received 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=12 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
n=6 Participants
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
n=6 Participants
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
10 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
Serious adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
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
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Treatment-related adverse events
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 155 days postdosePopulation: All participants who received 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=12 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
n=6 Participants
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
n=6 Participants
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-erenumab Antibodies
Binding antibody positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Anti-erenumab Antibodies
Neutralizing antibody positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose to 155 days postdosePopulation: All participants who received erenumab
Outcome measures
| Measure |
Healthy: Placebo
n=3 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Erenumab
|
0.0077 µg/mL
Standard Deviation 0.00395
|
0.302 µg/mL
Standard Deviation 0.145
|
1.17 µg/mL
Standard Deviation 0.646
|
6.25 µg/mL
Standard Deviation 2.03
|
9.18 µg/mL
Standard Deviation 1.97
|
47.8 µg/mL
Standard Deviation 4.09
|
15.2 µg/mL
Standard Deviation 4.78
|
9.93 µg/mL
Standard Deviation 3.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose to 155 days postdosePopulation: All participants who received erenumab
Outcome measures
| Measure |
Healthy: Placebo
n=3 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Erenumab
|
4.0 days
Interval 2.0 to 7.0
|
7.0 days
Interval 4.0 to 7.0
|
7.0 days
Interval 3.0 to 10.0
|
6.0 days
Interval 3.0 to 11.0
|
5.5 days
Interval 4.0 to 21.0
|
0.069 days
Interval 0.069 to 0.38
|
8.5 days
Interval 4.0 to 11.0
|
11 days
Interval 7.0 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose to 155 days postdosePopulation: All participants who received erenumab
Outcome measures
| Measure |
Healthy: Placebo
n=3 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab
|
0.0851 days*µg/mL
Standard Deviation 0.0169
|
4.01 days*µg/mL
Standard Deviation 2.07
|
23.5 days*µg/mL
Standard Deviation 15.5
|
171 days*µg/mL
Standard Deviation 60.9
|
332 days*µg/mL
Standard Deviation 57.9
|
614 days*µg/mL
Standard Deviation 112
|
652 days*µg/mL
Standard Deviation 221
|
367 days*µg/mL
Standard Deviation 102
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose to 155 days postdosePopulation: All participants who received erenumab
Outcome measures
| Measure |
Healthy: Placebo
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab
|
—
|
4.13 days*µg/mL
Standard Deviation 2.04
|
24.5 days*µg/mL
Standard Deviation 17.0
|
174 days*µg/mL
Standard Deviation 78.6
|
333 days*µg/mL
Standard Deviation 57.9
|
615 days*µg/mL
Standard Deviation 112
|
653 days*µg/mL
Standard Deviation 222
|
367 days*µg/mL
Standard Deviation 103
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort).Population: All participants for whom at least one post-dose capsaicin response measure was recorded.
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=12 Participants
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=3 Participants
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 Participants
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 Participants
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
n=6 Participants
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
n=6 Participants
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 4
|
8.6 ratio
Standard Error 1.15
|
9.9 ratio
Standard Error 1.32
|
5.6 ratio
Standard Error 1.32
|
2.9 ratio
Standard Error 1.22
|
1.7 ratio
Standard Error 1.22
|
1.4 ratio
Standard Error 1.22
|
1.4 ratio
Standard Error 1.22
|
1.9 ratio
Standard Error 1.22
|
11.9 ratio
Standard Error 1.20
|
2.0 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 15
|
8.6 ratio
Standard Error 1.15
|
9.0 ratio
Standard Error 1.32
|
3.6 ratio
Standard Error 1.32
|
1.4 ratio
Standard Error 1.22
|
2.2 ratio
Standard Error 1.22
|
1.3 ratio
Standard Error 1.22
|
1.7 ratio
Standard Error 1.22
|
2.2 ratio
Standard Error 1.22
|
12.4 ratio
Standard Error 1.20
|
2.1 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 29
|
7.2 ratio
Standard Error 1.15
|
8.3 ratio
Standard Error 1.32
|
10.8 ratio
Standard Error 1.32
|
3.0 ratio
Standard Error 1.22
|
2.0 ratio
Standard Error 1.22
|
1.1 ratio
Standard Error 1.22
|
1.6 ratio
Standard Error 1.22
|
1.9 ratio
Standard Error 1.22
|
13.1 ratio
Standard Error 1.20
|
1.8 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 43
|
8.4 ratio
Standard Error 1.19
|
—
|
—
|
—
|
1.2 ratio
Standard Error 1.26
|
1.8 ratio
Standard Error 1.22
|
2.0 ratio
Standard Error 1.22
|
2.1 ratio
Standard Error 1.22
|
12.0 ratio
Standard Error 1.20
|
2.1 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 64
|
8.3 ratio
Standard Error 1.21
|
—
|
—
|
—
|
—
|
1.5 ratio
Standard Error 1.22
|
2.2 ratio
Standard Error 1.22
|
2.3 ratio
Standard Error 1.22
|
12.4 ratio
Standard Error 1.20
|
2.0 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 85
|
10.7 ratio
Standard Error 1.21
|
—
|
—
|
—
|
—
|
4.6 ratio
Standard Error 1.26
|
3.9 ratio
Standard Error 1.22
|
2.6 ratio
Standard Error 1.22
|
12.0 ratio
Standard Error 1.20
|
7.4 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 99
|
7.6 ratio
Standard Error 1.21
|
—
|
—
|
—
|
—
|
5.1 ratio
Standard Error 1.22
|
5.9 ratio
Standard Error 1.22
|
4.3 ratio
Standard Error 1.22
|
12.2 ratio
Standard Error 1.20
|
10.2 ratio
Standard Error 1.20
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Day 127
|
11.4 ratio
Standard Error 1.36
|
—
|
—
|
—
|
—
|
—
|
—
|
9.1 ratio
Standard Error 1.22
|
—
|
—
|
|
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
End of study
|
9.6 ratio
Standard Error 1.15
|
8.2 ratio
Standard Error 1.32
|
10.5 ratio
Standard Error 1.32
|
9.0 ratio
Standard Error 1.22
|
3.6 ratio
Standard Error 1.22
|
7.6 ratio
Standard Error 1.22
|
8.3 ratio
Standard Error 1.22
|
8.8 ratio
Standard Error 1.22
|
12.0 ratio
Standard Error 1.20
|
9.8 ratio
Standard Error 1.20
|
Adverse Events
Healthy: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Healthy: Erenumab 1 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy: Erenumab 7 mg SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy: Erenumab 21 mg SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy: Erenumab 70 mg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy: Erenumab 140 mg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy: Erenumab 140 mg IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy: Erenumab 210 mg SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Migraine: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Migraine: Erenumab 140 mg SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy: Placebo
n=12 participants at risk
Healthy participants received a single dose of matching placebo administered by subcutaneous (SC) or intravenous (IV) injection.
|
Healthy: Erenumab 1 mg SC
n=3 participants at risk
Healthy participants received a single dose of erenumab 1 mg administered by subcutaneous injection.
|
Healthy: Erenumab 7 mg SC
n=3 participants at risk
Healthy participants received a single dose of erenumab 7 mg administered by subcutaneous injection.
|
Healthy: Erenumab 21 mg SC
n=6 participants at risk
Healthy participants received a single dose of erenumab 21 mg administered by subcutaneous injection.
|
Healthy: Erenumab 70 mg SC
n=6 participants at risk
Healthy participants received a single dose of erenumab 70 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg SC
n=6 participants at risk
Healthy participants received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
Healthy: Erenumab 140 mg IV
n=6 participants at risk
Healthy participants received a single dose of erenumab 140 mg administered by intravenous injection.
|
Healthy: Erenumab 210 mg SC
n=6 participants at risk
Healthy participants received a single dose of erenumab 210 mg administered by subcutaneous injection.
|
Migraine: Placebo
n=6 participants at risk
Participants with migraine received a single dose of placebo administered by subcutaneous injection.
|
Migraine: Erenumab 140 mg SC
n=6 participants at risk
Participants with migraine received a single dose of erenumab 140 mg administered by subcutaneous injection.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site haemorrhage
|
16.7%
2/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Genital infection fungal
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
3/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 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
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 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
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
66.7%
4/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 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%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
2/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 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
|
16.7%
2/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
1/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.3%
1/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/12 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/3 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/6 • From the initial dose of study drug up to 155 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
1/6 • From the initial dose of study drug up to 155 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