Trial Outcomes & Findings for A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients. (NCT NCT01753297)
NCT ID: NCT01753297
Last Updated: 2020-12-09
Results Overview
The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
226 participants
Primary outcome timeframe
Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Results posted on
2020-12-09
Participant Flow
The study was conducted in male subjects with high-risk prostate cancer who had undergone radical prostatectomy (RP) in 18 sites in China and Russia between Dec 2012 and Sep 2019. The study participation for each subject was at least 36 months. The end of study was when 61 biochemical relapse (BR) events were observed on the study global level.
Subjects had to have undergone RP no more than 8 weeks prior to randomisation, with post-RP prostate specific antigen (PSA) levels ≤0.2 nanograms/millilitre (ng/mL). The screening visit took place 6 weeks after RP (i.e. 2 weeks prior to randomisation). No other treatment for prostate cancer was permitted.
Participant milestones
| Measure |
Active Surveillance
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 milligrams (mg) triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
109
|
|
Overall Study
Received Triptorelin Treatment
|
0
|
105
|
|
Overall Study
COMPLETED
|
76
|
73
|
|
Overall Study
NOT COMPLETED
|
41
|
36
|
Reasons for withdrawal
| Measure |
Active Surveillance
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 milligrams (mg) triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
|
Overall Study
Withdrawal by Subject
|
26
|
23
|
|
Overall Study
Adverse Event (up to Month 36)
|
1
|
1
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Did not attend end of study visit
|
7
|
8
|
Baseline Characteristics
Only in subjects in the triptorelin arm with data available were included in the analysis.
Baseline characteristics by cohort
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 6.8 • n=117 Participants
|
65.4 years
STANDARD_DEVIATION 6.1 • n=109 Participants
|
65.3 years
STANDARD_DEVIATION 6.4 • n=226 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=117 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=226 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=117 Participants
|
109 Participants
n=109 Participants
|
226 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
Asian
|
84 Participants
n=117 Participants
|
79 Participants
n=109 Participants
|
163 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
Caucasian / White
|
33 Participants
n=117 Participants
|
30 Participants
n=109 Participants
|
63 Participants
n=226 Participants
|
|
Region of Enrollment
China
|
84 Participants
n=117 Participants
|
79 Participants
n=109 Participants
|
163 Participants
n=226 Participants
|
|
Region of Enrollment
Russia
|
33 Participants
n=117 Participants
|
30 Participants
n=109 Participants
|
63 Participants
n=226 Participants
|
|
PSA Levels
|
0.074 ng/mL
n=117 Participants
|
0.074 ng/mL
n=109 Participants
|
0.074 ng/mL
n=226 Participants
|
|
Testosterone Levels
|
—
|
462.00 nanograms per deciliter (ng/dL)
n=106 Participants • Only in subjects in the triptorelin arm with data available were included in the analysis.
|
462.00 nanograms per deciliter (ng/dL)
n=106 Participants • Only in subjects in the triptorelin arm with data available were included in the analysis.
|
|
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score
|
113.26 scores on a scale
STANDARD_DEVIATION 18.64 • n=117 Participants • Only subjects with data available were included in the analysis.
|
114.98 scores on a scale
STANDARD_DEVIATION 18.31 • n=106 Participants • Only subjects with data available were included in the analysis.
|
114.08 scores on a scale
STANDARD_DEVIATION 18.46 • n=223 Participants • Only subjects with data available were included in the analysis.
|
|
36-Item Short Form Health Survey (SF-36) Score
Physical Component Summary (PCS)
|
46.31 scores on a scale
STANDARD_DEVIATION 6.49 • n=117 Participants • Only subjects with data available were included in the analysis
|
47.37 scores on a scale
STANDARD_DEVIATION 6.62 • n=104 Participants • Only subjects with data available were included in the analysis
|
46.81 scores on a scale
STANDARD_DEVIATION 6.56 • n=221 Participants • Only subjects with data available were included in the analysis
|
|
36-Item Short Form Health Survey (SF-36) Score
Mental Component Summary (MCS)
|
48.18 scores on a scale
STANDARD_DEVIATION 9.78 • n=117 Participants • Only subjects with data available were included in the analysis
|
47.41 scores on a scale
STANDARD_DEVIATION 9.59 • n=104 Participants • Only subjects with data available were included in the analysis
|
47.81 scores on a scale
STANDARD_DEVIATION 9.67 • n=221 Participants • Only subjects with data available were included in the analysis
|
|
Gleason Score Prior to RP - Total Score in Categories
≤ 6
|
31 Participants
n=111 Participants • Only subjects with data available were included in the analysis.
|
27 Participants
n=105 Participants • Only subjects with data available were included in the analysis.
|
58 Participants
n=216 Participants • Only subjects with data available were included in the analysis.
|
|
Gleason Score Prior to RP - Total Score in Categories
= 7 (3+4)
|
32 Participants
n=111 Participants • Only subjects with data available were included in the analysis.
|
27 Participants
n=105 Participants • Only subjects with data available were included in the analysis.
|
59 Participants
n=216 Participants • Only subjects with data available were included in the analysis.
|
|
Gleason Score Prior to RP - Total Score in Categories
= 7 (4+3)
|
19 Participants
n=111 Participants • Only subjects with data available were included in the analysis.
|
20 Participants
n=105 Participants • Only subjects with data available were included in the analysis.
|
39 Participants
n=216 Participants • Only subjects with data available were included in the analysis.
|
|
Gleason Score Prior to RP - Total Score in Categories
≥ 8
|
29 Participants
n=111 Participants • Only subjects with data available were included in the analysis.
|
31 Participants
n=105 Participants • Only subjects with data available were included in the analysis.
|
60 Participants
n=216 Participants • Only subjects with data available were included in the analysis.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Number of Subjects With BR Events
|
35 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or first quartile (Q1) (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports median time to BRFS (with Q1 time to BRFS reported in the subsequent outcome measure).
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Median Time to BRFS
|
NA months
The median time to BRFS could not be estimated due to low numbers of events.
|
NA months
The median time to BRFS could not be estimated due to low numbers of events.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports Q1 time to BRFS.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Q1 Time to BRFS
|
30.0 months
Interval 18.6 to 42.1
|
39.1 months
Interval 29.9 to
The upper limit of 95% confidence interval (CI) could not be calculated as it was not reached.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports median time to EFS (with Q1 time to EFS reported in the subsequent outcome measure).
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Median Time to Event-Free Survival (EFS)
|
NA months
The median time to EFS could not be estimated due to low numbers of events.
|
NA months
The median time to EFS could not be estimated due to low numbers of events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports Q1 time to EFS.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Q1 Time to EFS
|
NA months
The Q1 time to EFS could not be estimated due to low numbers of events.
|
NA months
The Q1 time to EFS could not be estimated due to low numbers of events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports median time to OS (with Q1 time to OS reported in the subsequent outcome measure).
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Median Time to Overall Survival (OS)
|
NA months
The median time to OS could not be estimated due to low numbers of events.
|
NA months
The median time to OS could not be estimated due to low numbers of events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports Q1 time to OS.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Q1 Time to OS
|
NA months
The Q1 time to OS could not be estimated due to low numbers of events.
|
NA months
The Q1 time to OS could not be estimated due to low numbers of events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: Analysis was not performed for this outcome measure as no deaths due to prostate cancer were observed during the study.
Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with increased PSA \>0.2 ng/mL and with data available were included in the analysis.
PSADT was defined as the time from the first documented PSA increase \>0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports median time to PSADT (with Q1 time to PSADT reported in the subsequent outcome measure).
Outcome measures
| Measure |
Active Surveillance
n=38 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=27 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Median Time to PSA Doubling Time (PSADT)
|
NA months
Interval 15.2 to
The median and upper limit of 95% CI could not be calculated due to low number of events.
|
NA months
Interval 9.1 to
The median and upper limit of 95% CI could not be calculated due to low number of events.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with increased PSA \>0.2 ng/mL and with data available were included in the analysis.
PSADT was defined as the time from the first documented PSA increase \>0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports Q1 time to PSADT.
Outcome measures
| Measure |
Active Surveillance
n=38 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=27 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Q1 Time to PSADT
|
13.4 months
Interval 6.0 to
The upper limit of 95% CI could not be calculated as it was not reached.
|
9.1 months
Interval 1.6 to
The upper limit of 95% CI could not be calculated as it was not reached.
|
SECONDARY outcome
Timeframe: Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36.Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with data available were included in the analysis.
As per inclusion criterion, all subjects in both treatment groups had PSA levels ≤0.2 ng/mL at the screening visit. Starting from Month 3, any elevated PSA concentration \>0.2 ng/mL had to be confirmed by a second measurement performed 4 to 6 weeks later. No confirmation test was required after evidence of disease progression (BR and/or clinical disease progression). Subjects remained in the study until Month 36, even if they had a biochemical failure (PSA levels \>0.2 ng/mL); then they could enter follow-up. The percent change from baseline was defined as the percent change from the screening visit (Day -14). Percent change from baseline in PSA levels are reported as median values at Months 3, 6, 9, 12, 24 and 36. Note: the raw baseline values for PSA levels are reported in the Baseline Characteristics section.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=109 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Percent Change From Baseline in PSA Levels
Month 3
|
0.0 percent change
Interval 0.0 to 0.0
|
0.0 percent change
Interval 0.0 to 0.0
|
|
Percent Change From Baseline in PSA Levels
Month 6
|
0.0 percent change
Interval 0.0 to 0.0
|
0.0 percent change
Interval 0.0 to 0.0
|
|
Percent Change From Baseline in PSA Levels
Month 9
|
0.0 percent change
Interval 0.0 to 0.0
|
0.0 percent change
Interval 0.0 to 0.0
|
|
Percent Change From Baseline in PSA Levels
Month 12
|
0.0 percent change
Interval 0.0 to 0.0
|
0.0 percent change
Interval 0.0 to 0.0
|
|
Percent Change From Baseline in PSA Levels
Month 24
|
0.0 percent change
Interval 0.0 to 0.0
|
0.0 percent change
Interval 0.0 to 0.0
|
|
Percent Change From Baseline in PSA Levels
Month 36
|
0.0 percent change
Interval 0.0 to 25.7
|
0.0 percent change
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Months 3, 6 and 9.Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects in the triptorelin arm with data available were included in the analysis.
Serum testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline and at 3, 6 and 9 months only in subjects in the triptorelin arm. Change from baseline in testosterone levels are reported as median values at Months 3, 6 and 9. Note: the raw baseline values for testosterone levels are reported in the Baseline Characteristics section.
Outcome measures
| Measure |
Active Surveillance
n=106 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Change From Baseline in Serum Testosterone Levels
Month 3
|
-444.60 ng/dL
Interval -599.3 to -305.2
|
—
|
|
Change From Baseline in Serum Testosterone Levels
Month 6
|
-438.80 ng/dL
Interval -599.45 to -306.15
|
—
|
|
Change From Baseline in Serum Testosterone Levels
Month 9
|
-429.80 ng/dL
Interval -573.9 to -304.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Months 9, 24 and 36.Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with data available were included in the analysis.
Health-Related Quality of Life (HRQoL) was assessed using the FACT-P questionnaire (v4) at baseline and at 9, 24 and 36 months. The FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life. Change from baseline in FACT-P total score are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for FACT-P total score are reported in the Baseline Characteristics section.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=106 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
|---|---|---|
|
Change From Baseline in FACT-P Total Score
Month 36
|
2.76 score on a scale
Interval -1.96 to 7.49
|
3.81 score on a scale
Interval -1.05 to 8.67
|
|
Change From Baseline in FACT-P Total Score
Month 9
|
4.75 score on a scale
Interval 0.79 to 8.7
|
0.88 score on a scale
Interval -3.04 to 4.79
|
|
Change From Baseline in FACT-P Total Score
Month 24
|
1.48 score on a scale
Interval -2.86 to 5.83
|
3.78 score on a scale
Interval 0.22 to 7.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Months 9, 24 and 36.Population: The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with data available were included in the analysis.
HRQoL was assessed using the SF-36 health survey (v2) at baseline and at 9, 24 and 36 months. The 36 items cover 8 health domains: PF, role-physical, BP, SF, MH, RE, VT and GH. Subscale scores were normed to the 2009 US general population (mean=50; SD=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. Change from baseline in SF-36 PCS and MSC norm-based scores are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for PCS and MSC norm-based scores are reported in the Baseline Characteristics section.
Outcome measures
| Measure |
Active Surveillance
n=117 Participants
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin
n=104 Participants
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
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|---|---|---|
|
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
PCS: Month 9
|
2.78 score on a scale
Interval 1.23 to 4.34
|
2.60 score on a scale
Interval 1.22 to 3.98
|
|
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
MCS: Month 24
|
0.55 score on a scale
Interval -1.67 to 2.77
|
2.81 score on a scale
Interval 0.69 to 4.93
|
|
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
PCS: Month 24
|
4.49 score on a scale
Interval 2.91 to 6.06
|
3.46 score on a scale
Interval 1.87 to 5.04
|
|
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
PCS: Month 36
|
4.79 score on a scale
Interval 3.11 to 6.46
|
4.86 score on a scale
Interval 3.15 to 6.56
|
|
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
MCS: Month 9
|
1.80 score on a scale
Interval -0.35 to 3.95
|
4.26 score on a scale
Interval 2.23 to 6.28
|
|
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
MCS: Month 36
|
1.13 score on a scale
Interval -1.35 to 3.61
|
5.10 score on a scale
Interval 2.89 to 7.31
|
Adverse Events
Active Surveillance - Safety Population - Prior to Month 12
Serious events: 11 serious events
Other events: 27 other events
Deaths: 1 deaths
Triptorelin - Safety Population - Prior to Month 12
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Overall Safety Population - Posterior to Month 12
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Active Surveillance - Safety Population - Prior to Month 12
n=112 participants at risk
Representing AEs reported in the active surveillance arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded).
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin - Safety Population - Prior to Month 12
n=105 participants at risk
Representing TEAEs reported in the triptorelin arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded); corresponding to 12 months after the first triptorelin injection.
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
Overall Safety Population - Posterior to Month 12
n=217 participants at risk
Representing AEs reported in the overall safety population from Month 12 until end of study (Month 12 up to Month 36). Since no active study drug (ie, triptorelin) was administered to any subject during this period, AEs starting from the Month 12 visit were analysed and reported overall (ie, not separately for each treatment arm).
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|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Vascular disorders
Varicose vein
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
General disorders
Sudden death
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Retroperitoneum cyst
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.89%
1/112 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Vascular disorders
Hypertension
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Number of events 1 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
Other adverse events
| Measure |
Active Surveillance - Safety Population - Prior to Month 12
n=112 participants at risk
Representing AEs reported in the active surveillance arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded).
Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).
|
Triptorelin - Safety Population - Prior to Month 12
n=105 participants at risk
Representing TEAEs reported in the triptorelin arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded); corresponding to 12 months after the first triptorelin injection.
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).
|
Overall Safety Population - Posterior to Month 12
n=217 participants at risk
Representing AEs reported in the overall safety population from Month 12 until end of study (Month 12 up to Month 36). Since no active study drug (ie, triptorelin) was administered to any subject during this period, AEs starting from the Month 12 visit were analysed and reported overall (ie, not separately for each treatment arm).
|
|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
1.9%
2/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
General disorders
Asthenia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
General disorders
Oedema peripheral
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Vascular disorders
Hot flush
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
9.5%
10/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Herpes zoster
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Platelet count decreased
|
1.8%
2/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
1.9%
2/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
1.9%
2/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
General disorders
Fatigue
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
1.9%
2/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
4/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
3.8%
4/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.92%
2/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
General disorders
Pyrexia
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
1.9%
2/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
1.9%
2/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Vascular disorders
Hypertension
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Nervous system disorders
Headache
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Blood triglycerides increased
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.95%
1/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
2/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Blood glucose increased
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Pollakiuria
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Micturition urgency
|
1.8%
2/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Nervous system disorders
Dizziness
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Influenza
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Infections and infestations
Urinary tract infection
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Blood uric acid increased
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Toothache
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Gastritis
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
2/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
White blood cell count increased
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Psychiatric disorders
Insomnia
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Dysuria
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Investigations
Blood potassium increased
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Renal and urinary disorders
Renal cyst
|
1.8%
2/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.89%
1/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/112 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.00%
0/105 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
0.46%
1/217 • Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place