Trial Outcomes & Findings for Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study (NCT NCT02614183)
NCT ID: NCT02614183
Last Updated: 2020-06-17
Results Overview
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): 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; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
862 participants
Primary outcome timeframe
Baseline, Month 1 through Month 6
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
Placebo
Participants (pts) received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
|
Galcanezumab 120mg
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase.
|
Galcanezumab 240mg
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
|
|---|---|---|---|
|
Double Blind Treatment Phase
STARTED
|
434
|
214
|
214
|
|
Double Blind Treatment Phase
Received at Least One Dose of Study Drug
|
433
|
213
|
212
|
|
Double Blind Treatment Phase
Safety Population
|
432
|
206
|
220
|
|
Double Blind Treatment Phase
COMPLETED
|
351
|
177
|
175
|
|
Double Blind Treatment Phase
NOT COMPLETED
|
83
|
37
|
39
|
|
Post Treatment Follow-up Phase
STARTED
|
372
|
185
|
183
|
|
Post Treatment Follow-up Phase
Safety Population
|
372
|
183
|
185
|
|
Post Treatment Follow-up Phase
COMPLETED
|
354
|
179
|
171
|
|
Post Treatment Follow-up Phase
NOT COMPLETED
|
18
|
6
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants (pts) received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
|
Galcanezumab 120mg
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase.
|
Galcanezumab 240mg
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
|
|---|---|---|---|
|
Double Blind Treatment Phase
Adverse Event
|
10
|
9
|
7
|
|
Double Blind Treatment Phase
Lack of Efficacy
|
10
|
1
|
2
|
|
Double Blind Treatment Phase
Lost to Follow-up
|
18
|
9
|
5
|
|
Double Blind Treatment Phase
Physician Decision
|
7
|
3
|
2
|
|
Double Blind Treatment Phase
Pregnancy
|
2
|
1
|
3
|
|
Double Blind Treatment Phase
Protocol Violation
|
2
|
2
|
2
|
|
Double Blind Treatment Phase
Withdrawal by Subject
|
33
|
11
|
16
|
|
Double Blind Treatment Phase
Did not receive study drug
|
1
|
1
|
2
|
|
Post Treatment Follow-up Phase
Lost to Follow-up
|
5
|
3
|
5
|
|
Post Treatment Follow-up Phase
Physician Decision
|
5
|
1
|
2
|
|
Post Treatment Follow-up Phase
Protocol Violation
|
1
|
0
|
0
|
|
Post Treatment Follow-up Phase
Withdrawal by Subject
|
7
|
2
|
5
|
Baseline Characteristics
Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study
Baseline characteristics by cohort
| Measure |
Placebo
n=433 Participants
Participants received placebo by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
|
Galcanezumab 120mg
n=213 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection. Participants did not receive any intervention during post-treatment follow-up phase.
|
Galcanezumab 240mg
n=212 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months. Participants did not receive any intervention during post-treatment follow-up phase.
|
Total
n=858 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.33 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
40.93 years
STANDARD_DEVIATION 11.87 • n=7 Participants
|
39.07 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
40.67 years
STANDARD_DEVIATION 11.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
362 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
718 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
359 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
710 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
356 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
690 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
44 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
378 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
753 Participants
n=4 Participants
|
|
Migraine Headache Days (MHD) per month
|
9.08 Days per Month
STANDARD_DEVIATION 2.97 • n=5 Participants
|
9.21 Days per Month
STANDARD_DEVIATION 3.05 • n=7 Participants
|
9.14 Days per Month
STANDARD_DEVIATION 2.91 • n=5 Participants
|
9.13 Days per Month
STANDARD_DEVIATION 2.97 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): 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; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=425 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=210 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=208 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
|
-2.81 Days
Standard Error 0.24
|
-4.73 Days
Standard Error 0.29
|
-4.57 Days
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline.
Outcome measures
| Measure |
Placebo
n=425 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=210 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=208 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
≥50%
|
38.6 percentage of participants
Standard Error 1.7
|
62.3 percentage of participants
Standard Error 2.4
|
60.9 percentage of participants
Standard Error 2.5
|
|
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
≥75%
|
19.3 percentage of participants
Standard Error 1.4
|
38.8 percentage of participants
Standard Error 2.4
|
38.5 percentage of participants
Standard Error 2.4
|
|
Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
100%
|
6.2 percentage of participants
Standard Error 0.8
|
15.6 percentage of participants
Standard Error 1.6
|
14.6 percentage of participants
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline, Month 4 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
MSQ v2.1 was developed to address physical \& emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items 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. Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month \& baseline MHD category as fixed factors.
Outcome measures
| Measure |
Placebo
n=419 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=207 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=202 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain
|
24.69 units on a scale
Standard Error 1.07
|
32.43 units on a scale
Standard Error 1.31
|
32.09 units on a scale
Standard Error 1.32
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline value.
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.
Outcome measures
| Measure |
Placebo
n=425 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=210 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=208 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
|
-2.15 Days
Standard Error 0.21
|
-3.96 Days
Standard Error 0.25
|
-3.76 Days
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, Month 4 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and post baseline value.
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.
Outcome measures
| Measure |
Placebo
n=419 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=207 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=202 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating
|
-1.27 units on a scale
Standard Error 0.08
|
-1.59 units on a scale
Standard Error 0.10
|
-1.55 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.
Outcome measures
| Measure |
Placebo
n=425 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=210 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=208 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Overall Mean Change From Baseline in Headache Hours
|
-15.67 Hours per Month
Standard Error 2.24
|
-29.65 Hours per Month
Standard Error 2.70
|
-29.31 Hours per Month
Standard Error 2.72
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.
Outcome measures
| Measure |
Placebo
n=389 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=195 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=189 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
|
-14.87 units on a scale
Standard Error 1.37
|
-21.16 units on a scale
Standard Error 1.65
|
-20.06 units on a scale
Standard Error 1.68
|
SECONDARY outcome
Timeframe: Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.
Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject 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+ if there is at least one post-baseline result of ADA present with titer \>= 1: 20.
Outcome measures
| Measure |
Placebo
n=422 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=202 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=213 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab
TE ADA+
|
1.66 percentage of participants
|
3.47 percentage of participants
|
5.16 percentage of participants
|
|
Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab
Neutralizing Antibodies
|
1.42 percentage of participants
|
3.47 percentage of participants
|
5.16 percentage of participants
|
SECONDARY outcome
Timeframe: Month 6Population: All randomized participants who received at least one dose of study drug and had measurable serum concentrations.
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.
Outcome measures
| Measure |
Placebo
n=156 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=149 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab
|
15400 Nanogram per milliliter (ng/mL)
Standard Deviation 8340
|
29500 Nanogram per milliliter (ng/mL)
Standard Deviation 12300
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: All randomized participants who had received at least one dose of study drug and had measurable plasma concentrations.
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Outcome measures
| Measure |
Placebo
n=28 Participants
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg
n=165 Participants
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg
n=158 Participants
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|---|
|
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
|
0.888 ng/mL
Standard Deviation 1.89
|
4.25 ng/mL
Standard Deviation 1.79
|
5.13 ng/mL
Standard Deviation 2.43
|
Adverse Events
Placebo - Treatment Phase
Serious events: 5 serious events
Other events: 129 other events
Deaths: 0 deaths
Galcanezumab 120mg - Treatment Phase
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
Galcanezumab 240mg - Treatment Phase
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo - Post-Treatment Phase
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Galcanezumab 120mg - Post-Treatment Phase
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Galcanezumab 240mg - Post-Treatment Phase
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Treatment Phase
n=432 participants at risk
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg - Treatment Phase
n=206 participants at risk
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg - Treatment Phase
n=220 participants at risk
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
Placebo - Post-Treatment Phase
n=372 participants at risk
Participants didn't receive any intervention.
|
Galcanezumab 120mg - Post-Treatment Phase
n=183 participants at risk
Participants didn't receive any intervention.
|
Galcanezumab 240mg - Post-Treatment Phase
n=185 participants at risk
Participants didn't receive any intervention.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.54%
1/185 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.54%
1/185 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.54%
1/185 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.55%
1/183 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
General disorders
Asthenia
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.27%
1/372 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
2/432 • Number of events 2 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.23%
1/432 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.55%
1/183 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular breast carcinoma
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.49%
1/206 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/361 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/175 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/182 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/311 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.64%
1/156 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/156 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/361 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/175 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/182 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/311 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/156 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.64%
1/156 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/361 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/175 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/182 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/311 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.64%
1/156 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/156 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.54%
1/185 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/432 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.27%
1/372 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
1/432 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Vascular disorders
Deep vein thrombosis
|
0.23%
1/432 • Number of events 1 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/206 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/220 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
Other adverse events
| Measure |
Placebo - Treatment Phase
n=432 participants at risk
Participants received placebo by subcutaneous injection once a month for 6 months.
|
Galcanezumab 120mg - Treatment Phase
n=206 participants at risk
Participants received loading dose of 240mg (2 injections of 120mg each) galcanezumab at first doing visit followed by 120mg galcanezumab once a month for 5 months by subcutaneous injection.
|
Galcanezumab 240mg - Treatment Phase
n=220 participants at risk
Participants received 240mg galcanezumab by subcutaneous injection once a month for 6 months.
|
Placebo - Post-Treatment Phase
n=372 participants at risk
Participants didn't receive any intervention.
|
Galcanezumab 120mg - Post-Treatment Phase
n=183 participants at risk
Participants didn't receive any intervention.
|
Galcanezumab 240mg - Post-Treatment Phase
n=185 participants at risk
Participants didn't receive any intervention.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
17.4%
75/432 • Number of events 365 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
16.0%
33/206 • Number of events 158 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
20.5%
45/220 • Number of events 212 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
General disorders
Injection site reaction
|
0.93%
4/432 • Number of events 11 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
3.4%
7/206 • Number of events 14 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
5.5%
12/220 • Number of events 20 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/372 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/183 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
31/432 • Number of events 36 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
4.4%
9/206 • Number of events 11 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
6.8%
15/220 • Number of events 18 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
3.2%
12/372 • Number of events 14 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
3.3%
6/183 • Number of events 6 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
2.7%
5/185 • Number of events 5 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
15/432 • Number of events 15 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
3.9%
8/206 • Number of events 9 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
5.9%
13/220 • Number of events 13 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
2.2%
8/372 • Number of events 8 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
1.6%
3/183 • Number of events 3 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.00%
0/185 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
29/432 • Number of events 31 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
9.2%
19/206 • Number of events 23 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
3.6%
8/220 • Number of events 9 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
0.81%
3/372 • Number of events 3 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
1.6%
3/183 • Number of events 3 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
3.8%
7/185 • Number of events 7 • Up to 10 Months
All-Cause Mortality:All participants (pts) who received atleast 1 dose of study drug. SAE/AE:Eight pts discontinued after receiving loading dose (LD) of 240mg galcanezumab (GAL) in 120mg group (gp) moved to 240mg treatment gp. One pt randomized to placebo received GAL 120mg due to dosing error moved to 120mg treatment gp. Two pts who received only 240mg LD prior to discontinuation moved to 240mg post-treatment gp. There are gender specific adverse events only occurring in male or female pts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place