Trial Outcomes & Findings for A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (NCT NCT05127486)
NCT ID: NCT05127486
Last Updated: 2024-06-28
Results Overview
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 50% reduction in monthly migraine headache days from baseline (50% response rate) using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly migraine headache day.
COMPLETED
PHASE4
580 participants
Baseline, Month 1 through Month 3
2024-06-28
Participant Flow
Participant milestones
| Measure |
Galcanezumab
Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
|
Rimegepant
Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Overall Study
STARTED
|
287
|
293
|
|
Overall Study
Received at Least 1 Dose of the Study Drug
|
287
|
293
|
|
Overall Study
COMPLETED
|
261
|
266
|
|
Overall Study
NOT COMPLETED
|
26
|
27
|
Reasons for withdrawal
| Measure |
Galcanezumab
Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
|
Rimegepant
Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Physician Decision
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
13
|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
Baseline Characteristics
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Baseline characteristics by cohort
| Measure |
Galcanezumab
n=287 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=293 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
Total
n=580 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
42.3 years
STANDARD_DEVIATION 11.32 • n=4 Participants
|
42.0 years
STANDARD_DEVIATION 11.96 • n=27 Participants
|
|
Sex: Female, Male
Female
|
244 Participants
n=93 Participants
|
238 Participants
n=4 Participants
|
482 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
219 Participants
n=93 Participants
|
223 Participants
n=4 Participants
|
442 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
236 Participants
n=93 Participants
|
232 Participants
n=4 Participants
|
468 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
287 Participants
n=93 Participants
|
293 Participants
n=4 Participants
|
580 Participants
n=27 Participants
|
|
Number of Monthly Migraine Headache Days
|
8.5 days per month
STANDARD_DEVIATION 2.85 • n=93 Participants
|
8.3 days per month
STANDARD_DEVIATION 2.92 • n=4 Participants
|
8.4 days per month
STANDARD_DEVIATION 2.89 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 50% reduction in monthly migraine headache days from baseline (50% response rate) using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly migraine headache day.
Outcome measures
| Measure |
Galcanezumab
n=269 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=284 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.
|
62 percentage of participants
|
61 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 75% reduction in monthly migraine headache days from baseline (75% response rate) using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly migraine headache day.
Outcome measures
| Measure |
Galcanezumab
n=269 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=284 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period.
|
37 percentage of participants
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 100% reduction in monthly migraine headache days from baseline (100% response rate) using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly migraine headache day.
Outcome measures
| Measure |
Galcanezumab
n=269 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=284 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period.
|
18 percentage of participants
|
15 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean was derived from the average of month 1 through month 3. Least square (LS) mean was calculated using mixed model for repeated measures (MMRM) model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.
Outcome measures
| Measure |
Galcanezumab
n=269 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=284 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period.
|
-4.75 days per month
Standard Error 0.17
|
-4.39 days per month
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, Month 1Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.
Outcome measures
| Measure |
Galcanezumab
n=266 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=275 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1
|
-4.33 days per month
Standard Error 0.20
|
-3.77 days per month
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Month 2Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.
Outcome measures
| Measure |
Galcanezumab
n=256 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=268 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2
|
-4.81 days per month
Standard Error 0.20
|
-4.44 days per month
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.
Outcome measures
| Measure |
Galcanezumab
n=249 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=259 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3
|
-5.13 days per month
Standard Error 0.20
|
-4.94 days per month
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean was derived from the average of month 1 through month 3. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days with acute medications use, and baseline-by-month interaction as continuous variables.
Outcome measures
| Measure |
Galcanezumab
n=269 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=284 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache Across the 3-month Treatment Period.
|
-3.95 days per month
Standard Error 0.14
|
-3.47 days per month
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
The MSQ v2.1 is a 14-item questionnaire, participant-rated scale with a 4-week recall period that measures the impact of migraine on work or daily activities, relationships with family \& friends, leisure time, productivity, concentration, energy, tiredness \& feelings. It consists of 14 items that address 3 domains: * Role Function-Restrictive (RF-R), items 1-7 * Role Function-Preventive (RF-P), items 8-11 * Emotional Function (EF), items 12-14 Each item is scored from 1 (none of the time) to 6 (all of the time) and are reverse coded (value 6 to 1). Raw scores for each domain are computed as a sum of item responses, with the collective sum providing a total raw score. These were transformed to a 0-100 scale, with higher scores indicating better quality of life. LS mean was calculated using Analysis of covariance (ANCOVA) with main effects of treatment, the baseline number of migraine headache days category (\<8 vs \>=8), and the continuous fixed covariate of the baseline endpoint.
Outcome measures
| Measure |
Galcanezumab
n=271 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=269 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3
Total score
|
28.92 score on a scale
Standard Error 1.07
|
24.53 score on a scale
Standard Error 1.07
|
|
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3
RF-R
|
31.90 score on a scale
Standard Error 1.20
|
26.66 score on a scale
Standard Error 1.20
|
|
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3
RF-P
|
24.62 score on a scale
Standard Error 1.02
|
20.74 score on a scale
Standard Error 1.02
|
|
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3
EF
|
27.76 score on a scale
Standard Error 1.17
|
24.58 score on a scale
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome.
The MIDAS is a participant-rated scale that measures headache-related disability over a 3-month period. It consists of 5 items that measures number of days of work/school missed or days with productivity at work/school reduced to half or more; days with household work missed or days with productivity in household work reduced to half or more, and days of missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean was calculated using ANCOVA model with main effects of treatment, the baseline number of migraine headache days category (\<8 vs \>=8), and the continuous fixed covariate of the baseline endpoint.
Outcome measures
| Measure |
Galcanezumab
n=271 Participants
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=269 Participants
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3
|
-22.54 score on a scale
Standard Error 1.63
|
-20.11 score on a scale
Standard Error 1.63
|
Adverse Events
Galcanezumab
Rimegepant
Serious adverse events
| Measure |
Galcanezumab
n=287 participants at risk
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=293 participants at risk
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/287 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
0.34%
1/293 • Number of events 1 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
Other adverse events
| Measure |
Galcanezumab
n=287 participants at risk
Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo ODT every other day for 3 months was given to preserve blinding.
|
Rimegepant
n=293 participants at risk
Participants received 75 mg Rimegepant ODT every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
3/287 • Number of events 3 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
0.34%
1/293 • Number of events 1 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
3/287 • Number of events 3 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
0.00%
0/293 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
3/287 • Number of events 3 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.4%
4/293 • Number of events 4 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
General disorders
Fatigue
|
0.70%
2/287 • Number of events 2 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.4%
4/293 • Number of events 4 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
General disorders
Injection site pain
|
0.70%
2/287 • Number of events 2 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.4%
4/293 • Number of events 4 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Infections and infestations
Covid-19
|
4.2%
12/287 • Number of events 12 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.7%
5/293 • Number of events 5 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Infections and infestations
Influenza
|
1.0%
3/287 • Number of events 3 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
0.68%
2/293 • Number of events 2 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Infections and infestations
Nasopharyngitis
|
0.35%
1/287 • Number of events 1 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.7%
5/293 • Number of events 6 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Infections and infestations
Sinusitis
|
0.35%
1/287 • Number of events 1 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.0%
3/293 • Number of events 3 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
|
Nervous system disorders
Migraine
|
0.00%
0/287 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
1.4%
4/293 • Number of events 5 • Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60