Trial Outcomes & Findings for Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)" (NCT NCT02167893)
NCT ID: NCT02167893
Last Updated: 2017-03-29
Results Overview
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Recruitment status
COMPLETED
Target enrollment
11288 participants
Primary outcome timeframe
Baseline up to Week 96
Results posted on
2017-03-29
Participant Flow
Participants took part in the study at 758 investigative site in Japan from 13-Oct-2005 to 31-Dec-10.
Participants with a historical diagnosis of prostate cancer were treated with leuprorelin acetate 11.25 milligrams (mg) in daily medical practice along with adjuvant therapy were observed.
Participant milestones
| Measure |
Leuprorelin Acetate
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Overall Study
STARTED
|
11288
|
|
Overall Study
COMPLETED
|
11125
|
|
Overall Study
NOT COMPLETED
|
163
|
Reasons for withdrawal
| Measure |
Leuprorelin Acetate
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Overall Study
Investigator transferred
|
85
|
|
Overall Study
Investigator health reasons
|
10
|
|
Overall Study
Case report forms not collected
|
68
|
Baseline Characteristics
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
Baseline characteristics by cohort
| Measure |
Leuprorelin Acetate
n=11125 Participants
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Age, Continuous
|
75.88 years
STANDARD_DEVIATION 7.04 • n=99 Participants
|
|
Sex/Gender, Customized
Male
|
11125 participants
n=99 Participants
|
|
Body Mass Index
|
22.87 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.10 • n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
No lesions
|
333 participants
n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
Stage I
|
529 participants
n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
Stage II
|
5197 participants
n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
Stage III
|
2066 participants
n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
Stage IV
|
2608 participants
n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
Cannot be assessed
|
391 participants
n=99 Participants
|
|
Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)
Unknown
|
1 participants
n=99 Participants
|
|
Performance Status (at start of treatment with leuplin SR 11.25 mg injection)
0
|
8577 participants
n=99 Participants
|
|
Performance Status (at start of treatment with leuplin SR 11.25 mg injection)
1
|
1688 participants
n=99 Participants
|
|
Performance Status (at start of treatment with leuplin SR 11.25 mg injection)
2
|
518 participants
n=99 Participants
|
|
Performance Status (at start of treatment with leuplin SR 11.25 mg injection)
3
|
230 participants
n=99 Participants
|
|
Performance Status (at start of treatment with leuplin SR 11.25 mg injection)
4
|
72 participants
n=99 Participants
|
|
Performance Status (at start of treatment with leuplin SR 11.25 mg injection)
Unknown
|
40 participants
n=99 Participants
|
|
Predisposition to Hypersensitivity
Had predisposition to Hypersensitivity
|
530 participants
n=99 Participants
|
|
Predisposition to Hypersensitivity
Had no redisposition to Hypersensitivity
|
10594 participants
n=99 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
1 participants
n=99 Participants
|
|
Medical Complications
Had Complications
|
7234 participants
n=99 Participants
|
|
Medical Complications
Had no Complications
|
3889 participants
n=99 Participants
|
|
Medical Complications
Unknown
|
2 participants
n=99 Participants
|
|
Breakdown of Complications
Hypertension
|
3195 participants
n=99 Participants
|
|
Breakdown of Complications
Heart disease
|
1208 participants
n=99 Participants
|
|
Breakdown of Complications
Diabetes mellitus
|
1147 participants
n=99 Participants
|
|
Breakdown of Complications
Hyperlipidemia
|
799 participants
n=99 Participants
|
|
Breakdown of Complications
Cerebrovascular disease
|
547 participants
n=99 Participants
|
|
Breakdown of Complications
Malignant tumor
|
456 participants
n=99 Participants
|
|
Breakdown of Complications
Other
|
4617 participants
n=99 Participants
|
|
Prior Treatment for Prostate Cancer
Had prior treatment
|
9324 participants
n=99 Participants
|
|
Prior Treatment for Prostate Cancer
Had no prior treatment
|
1799 participants
n=99 Participants
|
|
Prior Treatment for Prostate Cancer
Unknown
|
2 participants
n=99 Participants
|
|
Breakdown for Prior Treatment for Prostate Cancer
LH-RH agonists (other than leuplin SR 11.25 mg)
|
7220 participants
n=99 Participants
|
|
Breakdown for Prior Treatment for Prostate Cancer
Other endocrine therapies
|
7596 participants
n=99 Participants
|
|
Breakdown for Prior Treatment for Prostate Cancer
Other chemotherapies
|
49 participants
n=99 Participants
|
|
Breakdown for Prior Treatment for Prostate Cancer
Total prostatectomy
|
734 participants
n=99 Participants
|
|
Breakdown for Prior Treatment for Prostate Cancer
Radiotherapy
|
561 participants
n=99 Participants
|
|
Breakdown for Prior Treatment for Prostate Cancer
Other treatments
|
72 participants
n=99 Participants
|
|
Healthcare Category
Outpatient
|
10629 participants
n=99 Participants
|
|
Healthcare Category
Inpatient
|
496 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 96Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Outcome measures
| Measure |
Leuprorelin Acetate
n=11125 Participants
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
|
2052 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 96Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Leuprorelin Acetate
n=11125 Participants
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Number of Participants Reporting One or More Serious Adverse Drug Reactions
|
188 participants
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeksPopulation: The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.
Outcome measures
| Measure |
Leuprorelin Acetate
n=9691 Participants
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
Stage I (N=467)
|
94.2 percentage of participants
Interval 91.4 to 96.2
|
|
Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
Stage II (N=4852)
|
92.0 percentage of participants
Interval 91.2 to 92.8
|
|
Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
Stage III (N=1926)
|
86.9 percentage of participants
Interval 85.2 to 88.4
|
|
Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
Stage IV (N=2446)
|
55.4 percentage of participants
Interval 53.3 to 57.5
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeks or death (which ever occurs first)Population: The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.
OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.
Outcome measures
| Measure |
Leuprorelin Acetate
n=9688 Participants
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Percentage of Participants With Overall Survival (OS) Based on TNM Classification
Stage I (N=466)
|
96.9 percentage of participants
Interval 94.6 to 98.2
|
|
Percentage of Participants With Overall Survival (OS) Based on TNM Classification
Stage II (N=4852)
|
97.4 percentage of participants
Interval 96.8 to 97.8
|
|
Percentage of Participants With Overall Survival (OS) Based on TNM Classification
Stage III (N=1927)
|
97.6 percentage of participants
Interval 96.7 to 98.2
|
|
Percentage of Participants With Overall Survival (OS) Based on TNM Classification
Stage IV (N=2443)
|
88.5 percentage of participants
Interval 87.0 to 89.8
|
SECONDARY outcome
Timeframe: Baseline up to 96 weeksPopulation: No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 96 weeksPopulation: No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.
Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Outcome measures
Outcome data not reported
Adverse Events
Leuprorelin Acetate
Serious events: 188 serious events
Other events: 1429 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Leuprorelin Acetate
n=11125 participants at risk
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Herpes zoster
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Injection site abscess
|
0.05%
6/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Lung abscess
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Pneumonia
|
0.09%
10/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Urinary tract infection
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Pseudomonas infection
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Infections and infestations
Respiratory tract infection
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.05%
6/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Delirium
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Depression
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Psychiatric disorders
Insomnia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Cerebellar infarction
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Cerebral infarction
|
0.14%
16/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Dementia
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Dysarthria
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Dyslalia
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Embolic stroke
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Hemiplegia
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Hyperreflexia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Optic neuritis
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Speech disorder
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Tremor
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Facial nerve disorder
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Eye disorders
Cataract
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Arrhythmia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Cardiac failure
|
0.08%
9/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Cardiomegaly
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Myocardial infarction
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Prinzmetal angina
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Cardiac disorder
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Hypertension
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Hot flush
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Aortic dissection rupture
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.06%
7/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.08%
9/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Colitis
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Constipation
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Melaena
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.04%
5/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Renal and urinary disorders
Incontinence
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Renal and urinary disorders
Renal failure
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Renal and urinary disorders
Urinary retention
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Asthenia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Chest discomfort
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Chest pain
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Crepitations
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Death
|
0.12%
13/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Face oedema
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Gait disturbance
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site erosion
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site erythema
|
0.11%
12/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site haemorrhage
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site induration
|
0.10%
11/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site pain
|
0.08%
9/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site pruritus
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site ulcer
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site warmth
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Malaise
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Oedema
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Oedema peripheral
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Pyrexia
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site swelling
|
0.09%
10/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Alanine aminotransferase increased
|
0.05%
6/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.05%
6/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Blood cholesterol increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Blood creatinine increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Blood triglycerides increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
C-reactive protein increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Chest X-ray abnormal
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Computerised tomogram abnormal
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Haemoglobin decreased
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Low density lipoprotein increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Platelet count decreased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
White blood cell count decreased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Investigations
Surfactant protein increased
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
4/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Surgical and medical procedures
Hospitalisation
|
0.02%
2/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
3/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Angina pectoris
|
0.04%
5/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.01%
1/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
Other adverse events
| Measure |
Leuprorelin Acetate
n=11125 participants at risk
Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
|
|---|---|
|
General disorders
Injection site erythema
|
2.5%
278/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
General disorders
Injection site induration
|
8.1%
904/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
|
Vascular disorders
Hot flush
|
2.2%
247/11125 • Baseline up to 96 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER