Trial Outcomes & Findings for A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine (NCT NCT03963232)
NCT ID: NCT03963232
Last Updated: 2023-03-28
Results Overview
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \[IHS\] International Classification of Headache Disorders 3rd edition \[ICHD-3\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
520 participants
Primary outcome timeframe
Baseline, 3 Months
Results posted on
2023-03-28
Participant Flow
The study was designed to be conducted in three phases: a 3-month double-blind treatment phase, an optional 3-month open-label treatment phase and a 4-month follow-up phase.
Participant milestones
| Measure |
Placebo
* Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.
* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg
* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
|---|---|---|
|
Double-Blind Treatment Phase
STARTED
|
259
|
261
|
|
Double-Blind Treatment Phase
Received at Least One Dose of Study Drug
|
259
|
261
|
|
Double-Blind Treatment Phase
COMPLETED
|
242
|
245
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
17
|
16
|
|
Open-Label Treatment Phase
STARTED
|
241
|
243
|
|
Open-Label Treatment Phase
COMPLETED
|
234
|
232
|
|
Open-Label Treatment Phase
NOT COMPLETED
|
7
|
11
|
|
Follow-up Phase
STARTED
|
243
|
247
|
|
Follow-up Phase
Entered From Double-blind Treatment Phase
|
7
|
11
|
|
Follow-up Phase
Entered From Open-Label Treatment Phase
|
236
|
236
|
|
Follow-up Phase
COMPLETED
|
236
|
238
|
|
Follow-up Phase
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Placebo
* Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.
* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg
* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
|---|---|---|
|
Double-Blind Treatment Phase
Adverse Event
|
0
|
6
|
|
Double-Blind Treatment Phase
Protocol Violation
|
1
|
1
|
|
Double-Blind Treatment Phase
Pregnancy
|
2
|
1
|
|
Double-Blind Treatment Phase
Withdrawal by Subject
|
13
|
5
|
|
Double-Blind Treatment Phase
Physician Decision
|
1
|
3
|
|
Open-Label Treatment Phase
Adverse Event
|
1
|
2
|
|
Open-Label Treatment Phase
Protocol Violation
|
0
|
2
|
|
Open-Label Treatment Phase
Withdrawal by Subject
|
5
|
7
|
|
Open-Label Treatment Phase
Pregnancy
|
1
|
0
|
|
Follow-up Phase
Withdrawal by Subject
|
7
|
5
|
|
Follow-up Phase
Protocol Violation
|
0
|
2
|
|
Follow-up Phase
Adverse Event
|
0
|
1
|
|
Follow-up Phase
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=259 Participants
* Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.
* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Galcanezumab 120 mg
n=261 Participants
* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
|
Total
n=520 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.80 years
STANDARD_DEVIATION 9.83 • n=99 Participants
|
37.20 years
STANDARD_DEVIATION 9.33 • n=107 Participants
|
37.00 years
STANDARD_DEVIATION 9.57 • n=206 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
384 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
239 Participants
n=99 Participants
|
239 Participants
n=107 Participants
|
478 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
198 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
396 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Monthly Migraine Headache Days (MHD)
|
8.34 days per month
STANDARD_DEVIATION 2.70 • n=99 Participants
|
8.16 days per month
STANDARD_DEVIATION 2.83 • n=107 Participants
|
8.25 days per month
STANDARD_DEVIATION 2.76 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \[IHS\] International Classification of Headache Disorders 3rd edition \[ICHD-3\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
|
-1.99 days per month
Standard Error 0.23
|
-3.81 days per month
Standard Error 0.23
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Participant having: * 30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder." * 50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder." * 75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder." * 100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
30% responder
|
50.3 Percentage of participants
Standard Error 2.4
|
73.0 Percentage of participants
Standard Error 2.1
|
|
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
50% responder
|
32.9 Percentage of participants
Standard Error 2.3
|
54.9 Percentage of participants
Standard Error 2.4
|
|
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
75% responder
|
12.7 Percentage of participants
Standard Error 1.6
|
29.2 Percentage of participants
Standard Error 2.1
|
|
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
100% responder
|
3.9 Percentage of participants
Standard Error 0.9
|
11.9 Percentage of participants
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=248 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.
|
13.94 score on a scale
Standard Error 0.88
|
21.01 score on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
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 is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.
|
-0.71 days per month
Standard Error 0.22
|
-2.49 days per month
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.
|
-2.09 days per month
Standard Error 0.24
|
-3.91 days per month
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Month 1 to Month 3Population: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.
|
12.4 percentage of participants
|
29.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.
|
-1.57 migraine attacks per month
Standard Error 0.12
|
-2.46 migraine attacks per month
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.
|
-12.83 hours per month
Standard Error 1.98
|
-31.72 hours per month
Standard Error 1.96
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=258 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=260 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.
|
-12.94 hours per month
Standard Error 2.06
|
-32.18 hours per month
Standard Error 2.03
|
SECONDARY outcome
Timeframe: Baseline, 3 MonthsPopulation: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=256 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=253 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.
|
-0.03 score on a scale
Standard Error 0.03
|
-0.19 score on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had baseline value, non-missing post baseline value at month 3.
PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=238 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=252 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.
|
-0.610 score on a scale
Standard Error 0.0961
|
-0.834 score on a scale
Standard Error 0.0930
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: All randomized participants who received at least one dose of study drug and had baseline value, non-missing post baseline value at month 3.
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days 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 change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=238 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=252 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.
|
-10.181 score on a scale
Standard Error 3.0597
|
-22.610 score on a scale
Standard Error 2.9582
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline ADA value.
A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 20.
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=248 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=259 Participants
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.
|
1.2 percentage of participants
|
9.3 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3Population: All randomized participants who received at least one dose of galcanezumab and had evaluable serum concentrations.
PK: Serum concentration of galcanezumab
Outcome measures
| Measure |
Placebo - Double-Blind Treatment Phase
n=260 Participants
Participants received placebo once per month SC for 3 months.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
|---|---|---|
|
Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.
|
14696 Nanogram per milliliter (ng/mL)
Standard Deviation 5675
|
—
|
Adverse Events
Placebo - Double-Blind Treatment Phase
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Galcanezumab 120mg - Double-Blind Treatment Phase
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo/Galcanezumab 120mg - Open-Label Treatment Phase
Serious events: 9 serious events
Other events: 12 other events
Deaths: 0 deaths
Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo - Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Galcanezumab 120mg - Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/Galcanezumab 120mg - Follow-up
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Galcanezumab 120mg/Galcanezumab 120mg - Follow-up
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Double-Blind Treatment Phase
n=259 participants at risk
Participants received placebo once per month SC for 3 months during this phase.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=261 participants at risk
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
Placebo/Galcanezumab 120mg - Open-Label Treatment Phase
n=241 participants at risk
After completion of Placebo double-blind phase, participants had an option to enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase
n=243 participants at risk
After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
|
Placebo - Follow-up
n=7 participants at risk
Participants entered follow-up phase from Placebo double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg - Follow-up
n=11 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Placebo/Galcanezumab 120mg - Follow-up
n=236 participants at risk
Participants entered follow-up phase from Placebo/Galcanezumab 120 mg open-label treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg/Galcanezumab 120mg - Follow-up
n=236 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab 120mg open-label treatment phase and were observed for 4 months. No treatments administered.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thymic cyst
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Eye disorders
Uveitis
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/243 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Appendicitis
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Covid-19 pneumonia
|
0.39%
1/259 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.38%
1/261 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.38%
1/261 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Mastitis
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/243 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/243 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Nervous system disorders
Migraine
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 2 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Nervous system disorders
Tension headache
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.42%
1/236 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.51%
1/196 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/188 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/180 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/175 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/8 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/177 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/173 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/196 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/188 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.56%
1/180 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/175 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/8 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/177 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/173 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/259 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.41%
1/241 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/196 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/188 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/180 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.57%
1/175 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/8 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/177 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/173 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.39%
1/259 • Number of events 1 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/261 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/241 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
Other adverse events
| Measure |
Placebo - Double-Blind Treatment Phase
n=259 participants at risk
Participants received placebo once per month SC for 3 months during this phase.
|
Galcanezumab 120mg - Double-Blind Treatment Phase
n=261 participants at risk
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
Placebo/Galcanezumab 120mg - Open-Label Treatment Phase
n=241 participants at risk
After completion of Placebo double-blind phase, participants had an option to enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
|
Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase
n=243 participants at risk
After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
|
Placebo - Follow-up
n=7 participants at risk
Participants entered follow-up phase from Placebo double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg - Follow-up
n=11 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.
|
Placebo/Galcanezumab 120mg - Follow-up
n=236 participants at risk
Participants entered follow-up phase from Placebo/Galcanezumab 120 mg open-label treatment phase and were observed for 4 months. No treatments administered.
|
Galcanezumab 120mg/Galcanezumab 120mg - Follow-up
n=236 participants at risk
Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab 120mg open-label treatment phase and were observed for 4 months. No treatments administered.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
6.2%
16/259 • Number of events 37 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
7.3%
19/261 • Number of events 47 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
2.5%
6/241 • Number of events 14 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/243 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
13/259 • Number of events 14 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
5.4%
14/261 • Number of events 15 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
2.5%
6/241 • Number of events 7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
2.9%
7/243 • Number of events 7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/7 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/11 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
0.00%
0/236 • Baseline to Follow-up (Up To 10 months)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Per protocol, AE analysis was planned per treatment regimen received in each study phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60