Trial Outcomes & Findings for AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines (NCT NCT04096326)
NCT ID: NCT04096326
Last Updated: 2023-07-28
Results Overview
Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
Baseline (Day 1) through Day 7
Results posted on
2023-07-28
Participant Flow
A total of 198 participants with moderate to severe glabellar lines (GL) were enrolled and randomized in a 3:1 ratio to receive AGN-151586 in 5 sequential AGN-151586 dose rising cohorts or Placebo in each of the 5 cohorts.
Participant milestones
| Measure |
Cohort 1: Placebo
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
32
|
12
|
28
|
11
|
27
|
10
|
30
|
9
|
31
|
|
Overall Study
COMPLETED
|
8
|
31
|
12
|
28
|
10
|
22
|
9
|
30
|
9
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
5
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COVID-19-related reasons
|
0
|
0
|
0
|
0
|
1
|
5
|
0
|
0
|
0
|
0
|
Baseline Characteristics
AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo
n=8 Participants
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 6.24 • n=39 Participants
|
52.8 years
STANDARD_DEVIATION 8.85 • n=41 Participants
|
47.0 years
STANDARD_DEVIATION 9.39 • n=35 Participants
|
50.9 years
STANDARD_DEVIATION 10.10 • n=31 Participants
|
50.1 years
STANDARD_DEVIATION 10.63 • n=146 Participants
|
47.5 years
STANDARD_DEVIATION 10.53 • n=19 Participants
|
39.0 years
STANDARD_DEVIATION 7.94 • n=147 Participants
|
45.3 years
STANDARD_DEVIATION 8.06 • n=193 Participants
|
51.1 years
STANDARD_DEVIATION 11.37
|
46.4 years
STANDARD_DEVIATION 10.30
|
48.3 years
STANDARD_DEVIATION 9.91 • n=19 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
24 Participants
n=19 Participants
|
9 Participants
n=147 Participants
|
26 Participants
n=193 Participants
|
9 Participants
|
30 Participants
|
182 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
0 Participants
|
1 Participants
|
16 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
8 Participants
n=19 Participants
|
3 Participants
n=147 Participants
|
12 Participants
n=193 Participants
|
0 Participants
|
7 Participants
|
52 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
19 Participants
n=19 Participants
|
7 Participants
n=147 Participants
|
18 Participants
n=193 Participants
|
9 Participants
|
24 Participants
|
146 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
6 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
1 Participants
|
2 Participants
|
4 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
2 Participants
n=193 Participants
|
1 Participants
|
2 Participants
|
10 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
26 Participants
n=19 Participants
|
10 Participants
n=147 Participants
|
28 Participants
n=193 Participants
|
7 Participants
|
26 Participants
|
175 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) through Day 7Population: mITT population included all randomized participants who received the study intervention and who had at least one postintervention investigator-rated FWS measurement at maximum frown.
Percentage of participants achieving a ≥ 2-grade improvement from baseline on the FWS according to investigator assessments of GL severity at maximum frown at any postintervention timepoint through Day 7 were reported. Investigators' assessments of the severity of GL at rest and maximum frown using the validated FWS was assessed using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. Higher scores indicate more severity. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
Cohort 1: Placebo
n=8 Participants
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 2-grade Improvement From Baseline on the FWS According to Investigator's Assessment at Any Postintervention Timepoint Through Day 7
|
0.0 percentage of participants
Upper and lower limit of 95% CI was not estimable as there was no participant with response having at least ≥ 2-grade improvement from baseline at any postintervention timepoint through Day 7.
|
40.6 percentage of participants
Interval 23.7 to 59.4
|
0.0 percentage of participants
Upper and lower limit of 95% CI was not estimable as there was no participant with response having at least ≥ 2-grade improvement from baseline at any postintervention timepoint through Day 7.
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
18.2 percentage of participants
Interval 2.3 to 51.8
|
70.4 percentage of participants
Interval 49.8 to 86.2
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
PRIMARY outcome
Timeframe: From first dose of study drug until the end of study (up to 42 days)Population: Safety population included all participants who received study intervention.
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. TEAEs were defined as events event began on or after the date and time of the study intervention; or the adverse event was present before the date and time of the study intervention, but increased in severity or became serious on or after the date and time of the study intervention.
Outcome measures
| Measure |
Cohort 1: Placebo
n=8 Participants
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience One or More Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
15 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
9 Participants
|
1 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until the end of study (up to 42 days)Population: Safety population included all participants who received study intervention.
Potentially clinically significant post intervention laboratory values included hematology, chemistry, and urinalysis as defined in the SAP.
Outcome measures
| Measure |
Cohort 1: Placebo
n=8 Participants
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Parameters Post Intervention
|
0 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until the end of study (up to 42 days)Population: Safety population included all participants who received study intervention.
Potentially clinically significant post intervention vital sign measurements included systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as defined in the SAP.
Outcome measures
| Measure |
Cohort 1: Placebo
n=8 Participants
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Signs Post Intervention
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until the end of study (up to 42 days)Population: Safety population included all participants who received study intervention.
Potentially clinically significant post intervention values in 12-lead ECG recordings included heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semi-supine or supine position as defined in the SAP. A post-baseline value is considered potentially clinically significant if it meets either the observed-value or the change-from-baseline criteria such as QRS interval observed value: ≥ 150 msec; PR interval observed value: ≥ 250 msec; QTcB observed value: \> 500 msec or change from baseline value: increase of \> 60 msec; QTcF observed value: \> 500 msec or change from baseline value: increase of \> 60 msec.
Outcome measures
| Measure |
Cohort 1: Placebo
n=8 Participants
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram Findings Post Intervention
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 42Population: Safety population included all participants who received study intervention. Overall number of participants analyzed are the number of participants available for analyses. Number analyzed indicates the number of participants with data available for analysis for the below categories.
Number of participants with positive anti-drug antibodies are reported. Binding and neutralizing anti-bodies are evaluated as anti-drug antibodies. Only participants with positive samples for binding antibodies have been analyzed for presence of neutralizing antibodies.
Outcome measures
| Measure |
Cohort 1: Placebo
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 Participants
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=26 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=1 Participants
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 Participants
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 Participants
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Binding Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs)
Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: AGN-151586
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: AGN-151586
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3: AGN-151586
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4: AGN-151586
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 5: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: AGN-151586
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Placebo
n=8 participants at risk
Participants received AGN-151586-matching placebo, intramuscular (IM) injections in the glabellar complex on Day 1 in Cohort 1.
|
Cohort 1: AGN-151586
n=32 participants at risk
Participants received AGN-151586 lowest dose, IM injections in the glabellar complex on Day 1.
|
Cohort 2: Placebo
n=12 participants at risk
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 2.
|
Cohort 2: AGN-151586
n=28 participants at risk
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 3: Placebo
n=11 participants at risk
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 3.
|
Cohort 3: AGN-151586
n=27 participants at risk
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 4: Placebo
n=10 participants at risk
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 4.
|
Cohort 4: AGN-151586
n=30 participants at risk
Participants received AGN-151586, IM injections in the glabellar complex on Day 1.
|
Cohort 5: Placebo
n=9 participants at risk
Participants received AGN-151586-matching placebo, IM injections in the glabellar complex on Day 1 in Cohort 5.
|
Cohort 5: AGN-151586
n=31 participants at risk
Participants received AGN-151586 highest dose, IM injections in the glabellar complex on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Injection site pain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
18.8%
6/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
25.0%
3/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
25.9%
7/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
20.0%
2/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
13.3%
4/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
19.4%
6/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Facial pain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Chills
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Injection site discomfort
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Injection site pruritus
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
11.1%
1/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.2%
2/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
16.7%
2/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
14.3%
4/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
18.2%
2/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
30.0%
3/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.7%
2/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.5%
2/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.2%
2/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
7.4%
2/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.2%
2/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.3%
1/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.3%
1/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
16.7%
2/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.3%
1/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
10.0%
1/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.7%
1/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.5%
2/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
6.5%
2/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.2%
1/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
9.1%
1/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Psychiatric disorders
Stress
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.3%
1/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
8.3%
1/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.6%
1/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
3.1%
1/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
|
Reproductive system and breast disorders
Breast induration
|
12.5%
1/8 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/32 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/12 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/28 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/11 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/27 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/10 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/30 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/9 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
0.00%
0/31 • All-cause mortality was reported from enrollment to the end of study; median time on follow-up was 42 days for the placebo and AGN-151586 arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 42 days after the last dose of study drug.
Safety population included all participants who received study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place