Trial Outcomes & Findings for Biomarker and Genetic Predictors of Erenumab Treatment Response (NCT NCT04265755)
NCT ID: NCT04265755
Last Updated: 2024-06-07
Results Overview
A migraine day was defined as a calendar day (00:00 to 23:59) in which the participant reports any migraine headache or takes any triptan-based acute migraine-specific medication. At least a 50% reduction from Baseline in MMDs was determined if: (average number of migraine days per month during the last 3 months \[months 4, 5, and 6\] of the 24-week Open-label Treatment Period minus number of migraine days during the 4-week Baseline Period) / number of migraine days during the 4-week Baseline Period \* 100, was less than or equal to -50%.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1406 participants
Primary outcome timeframe
4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment Period
Results posted on
2024-06-07
Participant Flow
A total of 1406 participants were enrolled in Denmark and Iceland between October 2020 and January 2023. As pre-specified, the primary objective of the study was to assess the relationship between migraine polygenic risk score (mPRS) and the reduction in mean monthly migraine days (MMD) after using erenumab, regardless of erenumab dose received.
The study consisted of the following: * A Screening Period of up to 3 weeks. * A Baseline Period of 4 - 5 weeks to collect data on migraine headaches and acute headache medication use. * A 24-week, Open-label Treatment Period.
Participant milestones
| Measure |
Erenumab 70 mg/140 mg
Participants were enrolled into the Open-label Treatment Period and received erenumab 70 mg or 140 mg administered subcutaneously (SC) once every 4 weeks (Q4W) at the discretion of the investigator. Per protocol, dose switching between erenumab 70 mg and 140 mg was permitted at Week 12. However, participants could switch dose before or after Week 12 if needed based on investigator discretion.
Dose comparison was not pre-specified.
|
|---|---|
|
Overall Study
STARTED
|
1406
|
|
Overall Study
Dose Switch From Baseline Dose
|
504
|
|
Overall Study
COMPLETED
|
1353
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Erenumab 70 mg/140 mg
Participants were enrolled into the Open-label Treatment Period and received erenumab 70 mg or 140 mg administered subcutaneously (SC) once every 4 weeks (Q4W) at the discretion of the investigator. Per protocol, dose switching between erenumab 70 mg and 140 mg was permitted at Week 12. However, participants could switch dose before or after Week 12 if needed based on investigator discretion.
Dose comparison was not pre-specified.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
39
|
|
Overall Study
Decision by sponsor
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Biomarker and Genetic Predictors of Erenumab Treatment Response
Baseline characteristics by cohort
| Measure |
Erenumab 70 mg/140 mg
n=1406 Participants
Participants were enrolled into the Open-label Treatment Period and received erenumab 70 mg or 140 mg administered SC Q4W at the discretion of the investigator. Per protocol, dose switching between erenumab 70 mg and 140 mg was permitted at Week 12. However, participants could switch dose before or after Week 12 if needed based on investigator discretion.
Dose comparison was not pre-specified.
|
|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1228 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1384 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1353 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
23 Participants
n=5 Participants
|
|
MMDs During the Baseline Period
|
12.82 days / month
STANDARD_DEVIATION 5.92 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment PeriodPopulation: Efficacy Analysis Set: consisted of a subset of participants in FAS who received at least 1 dose of investigational product.
A migraine day was defined as a calendar day (00:00 to 23:59) in which the participant reports any migraine headache or takes any triptan-based acute migraine-specific medication. At least a 50% reduction from Baseline in MMDs was determined if: (average number of migraine days per month during the last 3 months \[months 4, 5, and 6\] of the 24-week Open-label Treatment Period minus number of migraine days during the 4-week Baseline Period) / number of migraine days during the 4-week Baseline Period \* 100, was less than or equal to -50%.
Outcome measures
| Measure |
Erenumab 70 mg/140 mg
n=1368 Participants
Participants were enrolled into the Open-label Treatment Period and received erenumab 70 mg or 140 mg administered SC Q4W at the discretion of the investigator. Per protocol, dose switching between erenumab 70 mg and 140 mg was permitted at Week 12. However, participants could switch dose before or after Week 12 if needed based on investigator discretion.
Dose comparison was not pre-specified.
|
|---|---|
|
Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS
|
54.9 percentage of participants
Interval 52.22 to 57.56
|
Adverse Events
Erenumab 70 mg
Serious events: 8 serious events
Other events: 172 other events
Deaths: 1 deaths
Erenumab 70 mg Switch to 140 mg
Serious events: 8 serious events
Other events: 391 other events
Deaths: 0 deaths
Erenumab 140 mg Switch to 70 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Erenumab 140 mg
Serious events: 14 serious events
Other events: 417 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erenumab 70 mg
n=214 participants at risk
Participants who were initially enrolled into the Open-label Treatment Period and received erenumab 70 mg administered SC Q4W at the discretion of the investigator.
|
Erenumab 70 mg Switch to 140 mg
n=497 participants at risk
Participants who initially received erenumab 70 mg administered SC Q4W and were dose switched to erenumab 140 mg per investigation's discretion.
|
Erenumab 140 mg Switch to 70 mg
n=7 participants at risk
Participants who initially received erenumab 140 mg administered SC Q4W and were dose switched to erenumab 70 mg per investigation's discretion.
|
Erenumab 140 mg
n=688 participants at risk
Participants who were initially enrolled into the Open-label Treatment Period and received erenumab 140 mg administered SC Q4W at the discretion of the investigator.
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.40%
2/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Psychogenic seizure
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.29%
2/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Erenumab 70 mg
n=214 participants at risk
Participants who were initially enrolled into the Open-label Treatment Period and received erenumab 70 mg administered SC Q4W at the discretion of the investigator.
|
Erenumab 70 mg Switch to 140 mg
n=497 participants at risk
Participants who initially received erenumab 70 mg administered SC Q4W and were dose switched to erenumab 140 mg per investigation's discretion.
|
Erenumab 140 mg Switch to 70 mg
n=7 participants at risk
Participants who initially received erenumab 140 mg administered SC Q4W and were dose switched to erenumab 70 mg per investigation's discretion.
|
Erenumab 140 mg
n=688 participants at risk
Participants who were initially enrolled into the Open-label Treatment Period and received erenumab 140 mg administered SC Q4W at the discretion of the investigator.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
43.0%
92/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
38.8%
193/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
71.4%
5/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
40.7%
280/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.3%
7/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.40%
2/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.0%
7/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
7.0%
15/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.4%
37/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.8%
47/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
5.6%
12/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.2%
16/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
14/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
4.2%
9/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
6.8%
34/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
9.3%
20/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.2%
36/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.4%
7/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.29%
2/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
1.9%
4/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.2%
6/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.73%
5/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Immunisation reaction
|
7.9%
17/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.0%
35/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.15%
1/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
22.9%
49/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
20.7%
103/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
8.3%
57/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.20%
1/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.29%
2/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
10/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.0%
35/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.2%
15/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
21/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
15.3%
76/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.5%
17/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
12/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.4%
12/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.44%
3/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.6%
12/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
3.6%
18/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.7%
12/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
2.8%
6/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.6%
8/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.0%
14/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Psychogenic seizure
|
0.00%
0/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.0%
15/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
2.8%
14/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.44%
3/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.3%
37/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
71/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
10.5%
72/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.47%
1/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
5/214 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
1.8%
9/497 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
42.9%
3/7 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
4.8%
33/688 • Up to 24 weeks
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER