Trial Outcomes & Findings for A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS (NCT NCT04121221)
NCT ID: NCT04121221
Last Updated: 2026-08-05
Results Overview
ARR during the 52 weeks of the PC period as derived from the total number of confirmed relapses
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1016 participants
Primary outcome timeframe
52 weeks
Results posted on
2026-08-05
Participant Flow
A total of 1108 participants were screened in this study, and 92 participants failed screening. Of these, 92 did not meet eligibility criteria.
1016 participants were enrolled and randomized in the placebo-controlled (PC) double-blind period. Participants were randomized 1:1 to the treatment arms
Participant milestones
| Measure |
Early Start: GA Depot 40 mg
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period, and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Double-Blind Placebo-Controlled Period
STARTED
|
508
|
508
|
|
Double-Blind Placebo-Controlled Period
COMPLETED
|
379
|
442
|
|
Double-Blind Placebo-Controlled Period
NOT COMPLETED
|
129
|
66
|
|
Open-Label Period
STARTED
|
347
|
416
|
|
Open-Label Period
COMPLETED
|
293
|
332
|
|
Open-Label Period
NOT COMPLETED
|
54
|
84
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
Baseline characteristics by cohort
| Measure |
Early Start: GA Depot 40 mg
n=508 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period, and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=508 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Total
n=1016 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 Years
STANDARD_DEVIATION 9.08 • n=20 Participants
|
36.9 Years
STANDARD_DEVIATION 9.33 • n=20 Participants
|
36.8 Years
STANDARD_DEVIATION 9.20 • n=40 Participants
|
|
Sex: Female, Male
Female
|
345 Participants
n=20 Participants
|
361 Participants
n=20 Participants
|
706 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=20 Participants
|
147 Participants
n=20 Participants
|
310 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
508 Participants
n=20 Participants
|
508 Participants
n=20 Participants
|
1016 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
501 Participants
n=20 Participants
|
501 Participants
n=20 Participants
|
1002 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Body Mass Index (BMI)
|
23.96 kg/m^2
STANDARD_DEVIATION 4.44 • n=20 Participants
|
24.17 kg/m^2
STANDARD_DEVIATION 4.78 • n=20 Participants
|
24.07 kg/m^2
STANDARD_DEVIATION 4.61 • n=40 Participants
|
|
Time from Onset of MS Symptom
|
7.33 Years
STANDARD_DEVIATION 6.24 • n=20 Participants
|
6.94 Years
STANDARD_DEVIATION 6.45 • n=20 Participants
|
7.14 Years
STANDARD_DEVIATION 6.34 • n=40 Participants
|
|
Time since date of RMS diagnosis
|
4.86 Years
STANDARD_DEVIATION 5.42 • n=20 Participants
|
4.76 Years
STANDARD_DEVIATION 5.52 • n=20 Participants
|
4.81 Years
STANDARD_DEVIATION 5.47 • n=40 Participants
|
|
Number of T1 Enhancing Lesions at Baseline
|
1.21 Lesions
STANDARD_DEVIATION 2.11 • n=20 Participants
|
1.17 Lesions
STANDARD_DEVIATION 2.09 • n=20 Participants
|
1.19 Lesions
STANDARD_DEVIATION 2.10 • n=40 Participants
|
|
Number of T2 hyperintense lesions at Baseline
|
40.40 Lesions
STANDARD_DEVIATION 26.84 • n=20 Participants
|
41.79 Lesions
STANDARD_DEVIATION 27.12 • n=20 Participants
|
41.10 Lesions
STANDARD_DEVIATION 26.97 • n=40 Participants
|
PRIMARY outcome
Timeframe: 52 weeksARR during the 52 weeks of the PC period as derived from the total number of confirmed relapses
Outcome measures
| Measure |
Early Start: GA Depot 40 mg
n=508 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=508 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Annualized Relapse Rate (ARR)
|
0.182 Relapses per participant per year
Standard Error 0.022
|
0.260 Relapses per participant per year
Standard Error 0.029
|
SECONDARY outcome
Timeframe: 52 weeksCumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
Outcome measures
| Measure |
Early Start: GA Depot 40 mg
n=447 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=470 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Changes in Brain MRI (Number of T1 Lesions)
|
1.528 Lesions
Standard Error 0.152
|
2.138 Lesions
Standard Error 0.211
|
SECONDARY outcome
Timeframe: 52 weeksCumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
Outcome measures
| Measure |
Early Start: GA Depot 40 mg
n=447 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=470 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Changes in Brain MRI (Number of T2 Lesions)
|
3.816 Lesions
Standard Error 0.305
|
4.470 Lesions
Standard Error 0.349
|
SECONDARY outcome
Timeframe: 52 weeksChange from baseline to Week 52 in hyperintense T2-lesion volume.
Outcome measures
| Measure |
Early Start: GA Depot 40 mg
n=360 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=419 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Hyperintense T2-lesion Volume Change
|
-404.873 μl
Standard Error 123.518
|
-287.953 μl
Standard Error 116.852
|
SECONDARY outcome
Timeframe: 52 weeksChange from baseline to Week 52 in enhancing T1-lesion volume.
Outcome measures
| Measure |
Early Start: GA Depot 40 mg
n=358 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=419 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Enhancing T1-lesion Volume Change
|
-10.270 μl
Standard Error 20.972
|
0.697 μl
Standard Error 19.633
|
POST_HOC outcome
Timeframe: 52 weeksPost hoc analysis - Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline (over-dispersed Poisson regression model)
Outcome measures
| Measure |
Early Start: GA Depot 40 mg
n=447 Participants
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period and then continued the same treatment in the Open-Label Period from Month 12 up to 24 months until the study ended.
|
Delayed Start: Placebo
n=470 Participants
Participants received placebo IM injections every 4 weeks for 12 months during the Double-blind Placebo-Controlled Period. Participants were then switched to glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the Open-Label Period from Month 12 up to 24 months until the study ended.
|
|---|---|---|
|
Changes in Brain MRI (Number of T2 Lesions)
|
3.743 Lesions
Standard Error 0.302
|
4.527 Lesions
Standard Error 0.336
|
Adverse Events
Early Start: GA Depot 40 mg - PC Period
Serious events: 24 serious events
Other events: 320 other events
Deaths: 0 deaths
Delayed Start: Placebo - PC Period
Serious events: 9 serious events
Other events: 230 other events
Deaths: 2 deaths
Early Start: GA 40 Depot mg - OL Period
Serious events: 4 serious events
Other events: 107 other events
Deaths: 0 deaths
Delayed Start: GA Depot 40 mg - OL Period
Serious events: 10 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early Start: GA Depot 40 mg - PC Period
n=508 participants at risk
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the 12-month Double-blind Placebo-Controlled Period and continued the same treatment during the Open-label Period from Month 12 up to Month 24 until the study ended.
|
Delayed Start: Placebo - PC Period
n=508 participants at risk
Participants received placebo IM injections every 4 weeks during the 12-month Double-blind Placebo-Controlled Period.
|
Early Start: GA 40 Depot mg - OL Period
n=347 participants at risk
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the 12-month Double-blind Placebo-Controlled Period and continued the same treatment during the Open-label Period from Month 12 up to Month 24 until the study ended.
|
Delayed Start: GA Depot 40 mg - OL Period
n=416 participants at risk
After completing the Double-blind Placebo-Controlled Period, participants switched to glatiramer acetate (GA) Depot 40 mg IM injections every 4 weeks from Month 12 through Month 24 until the study ended.
This 'Delayed Start' treatment started at Month 12 and continued until the study ended (up to 24 Months).
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.79%
4/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Pneumonia
|
0.39%
2/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Abscess
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Abscess limb
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.29%
1/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
COVID-19
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Coronavirus infection
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.39%
2/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.72%
3/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
HIV infection
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.29%
1/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.29%
1/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.29%
1/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Blood and lymphatic system disorders
Anemia
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Immune system disorders
Anaphylactic reaction
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Nervous system disorders
Sciatic nerve neuropathy
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Eye disorders
Retinal artery occlusion
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Eye disorders
Uveitis
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Hepatobiliary disorders
Sphincter of Oddi dysfunction
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.59%
3/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.39%
2/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Pregnancy, puerperium and perinatal conditions
Risk of future pregnancy miscarriage
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.20%
1/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.00%
0/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.24%
1/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
Other adverse events
| Measure |
Early Start: GA Depot 40 mg - PC Period
n=508 participants at risk
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the 12-month Double-blind Placebo-Controlled Period and continued the same treatment during the Open-label Period from Month 12 up to Month 24 until the study ended.
|
Delayed Start: Placebo - PC Period
n=508 participants at risk
Participants received placebo IM injections every 4 weeks during the 12-month Double-blind Placebo-Controlled Period.
|
Early Start: GA 40 Depot mg - OL Period
n=347 participants at risk
Participants received glatiramer acetate (GA) Depot 40 mg by IM injection every 4 weeks during the 12-month Double-blind Placebo-Controlled Period and continued the same treatment during the Open-label Period from Month 12 up to Month 24 until the study ended.
|
Delayed Start: GA Depot 40 mg - OL Period
n=416 participants at risk
After completing the Double-blind Placebo-Controlled Period, participants switched to glatiramer acetate (GA) Depot 40 mg IM injections every 4 weeks from Month 12 through Month 24 until the study ended.
This 'Delayed Start' treatment started at Month 12 and continued until the study ended (up to 24 Months).
|
|---|---|---|---|---|
|
Infections and infestations
Coronavirus infection
|
7.9%
40/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
8.1%
41/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
4.6%
16/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
4.8%
20/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Nervous system disorders
Headache
|
5.5%
28/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
10.0%
51/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
4.6%
16/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
5.5%
23/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Injection site pain
|
29.3%
149/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
22.0%
112/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
11.0%
38/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
10.6%
44/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Pyrexia
|
21.3%
108/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
5.5%
28/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
6.9%
24/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
7.5%
31/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Injection site induration
|
17.7%
90/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
8.5%
43/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
8.6%
30/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
11.1%
46/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Influenza like illness
|
8.7%
44/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
3.0%
15/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
6.1%
21/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
7.2%
30/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Injection site mass
|
5.9%
30/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
2.6%
13/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
1.4%
5/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
0.72%
3/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Injection site erythema
|
7.3%
37/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
3.5%
18/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
1.4%
5/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
3.1%
13/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
General disorders
Injection site swelling
|
6.3%
32/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
2.2%
11/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
2.6%
9/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
1.7%
7/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
|
Investigations
Body temperature increased
|
15.2%
77/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
6.3%
32/508 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
9.2%
32/347 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
7.9%
33/416 • Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24
Death details: * Delayed Start (Placebo, PC period): There were 2 deaths during the PC period. * Delayed Start (GA Depot 40 mg, OL period): No deaths were reported. * Early Start (GA Depot 40 mg, PC and OL periods): No deaths were reported in the GA Depot group during the PC and OL periods.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place