Trial Outcomes & Findings for A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide (NCT NCT01977651)
NCT ID: NCT01977651
Last Updated: 2024-12-06
Results Overview
Percentage of evaluable participants with at least one confirmed seizure as adjudicated by the IAC during the first 4 months of treatment were reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
424 participants
Primary outcome timeframe
Day 1 up to week 17 (end of 4-month treatment period)
Results posted on
2024-12-06
Participant Flow
Study enrolled male participants with histologically-confirmed metastatic adenocarcinoma of prostate with ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or a prior orchiectomy. Participants were evaluated by a neurologist who determined they had at least 1 risk factor for seizure.
Participants who met all inclusion and none of the exclusion criteria were enrolled in the study, completing a 4-month treatment period. Participants who benefited from the treatment were allowed to continue in the extension period. A total 424 participants were enrolled and 423 participants received the study drug.
Participant milestones
| Measure |
Enzalutamide 160 mg
Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.
|
|---|---|
|
4 Month Treatment Period
STARTED
|
423
|
|
4 Month Treatment Period
COMPLETED
|
322
|
|
4 Month Treatment Period
NOT COMPLETED
|
101
|
|
1 Year Extension Period
STARTED
|
287
|
|
1 Year Extension Period
COMPLETED
|
157
|
|
1 Year Extension Period
NOT COMPLETED
|
130
|
|
Post 1 Year Extension Period
STARTED
|
145
|
|
Post 1 Year Extension Period
COMPLETED
|
1
|
|
Post 1 Year Extension Period
NOT COMPLETED
|
144
|
Reasons for withdrawal
| Measure |
Enzalutamide 160 mg
Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.
|
|---|---|
|
4 Month Treatment Period
Adverse Event
|
34
|
|
4 Month Treatment Period
Death
|
3
|
|
4 Month Treatment Period
Progressive Disease
|
43
|
|
4 Month Treatment Period
Withdrawal by Subject
|
17
|
|
4 Month Treatment Period
Physician Decision
|
4
|
|
1 Year Extension Period
Adverse Event
|
14
|
|
1 Year Extension Period
Death
|
10
|
|
1 Year Extension Period
Lost to Follow-up
|
2
|
|
1 Year Extension Period
Progressive Disease
|
86
|
|
1 Year Extension Period
Withdrawal by Subject
|
11
|
|
1 Year Extension Period
Physician Decision
|
6
|
|
1 Year Extension Period
Miscellaneous
|
1
|
|
Post 1 Year Extension Period
Adverse Event
|
5
|
|
Post 1 Year Extension Period
Death
|
13
|
|
Post 1 Year Extension Period
Progressive Disease
|
60
|
|
Post 1 Year Extension Period
Withdrawal by Subject
|
13
|
|
Post 1 Year Extension Period
Physician Decision
|
4
|
|
Post 1 Year Extension Period
Miscellaneous
|
49
|
Baseline Characteristics
A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
Baseline characteristics by cohort
| Measure |
Enzalutamide 160 mg
n=423 Participants
Participants received 160 mg of enzalutamide orally once a day, for 4 months.
|
|---|---|
|
Age, Continuous
|
73.2 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
423 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
381 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NO DATA
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
4 Participants
n=5 Participants
|
|
Ethnicity
NOT HISPANIC OR LATINO
|
331 Participants
n=5 Participants
|
|
Ethnicity
HISPANIC OR LATINO
|
89 Participants
n=5 Participants
|
|
Ethnicity
NO DATA
|
3 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) At Study Entry
Grade 0
|
188 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) At Study Entry
Grade 1
|
190 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) At Study Entry
Grade 2
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to week 17 (end of 4-month treatment period)Population: The seizure risk evaluation set (SRES) consisted of all participants with a confirmed seizure during the 4-month treatment period of the study or who completed at least 3 months (75 percent \[%\]) of the planned treatment.
Percentage of evaluable participants with at least one confirmed seizure as adjudicated by the IAC during the first 4 months of treatment were reported.
Outcome measures
| Measure |
Enzalutamide 160 mg
n=366 Participants
Participants received 160 mg of enzalutamide orally once a day, for 4 months.
|
|---|---|
|
The Percentage of Evaluable Participants With at Least One Confirmed Seizure as Adjudicated by the Independent Adjudication Committee (IAC)
|
1.1 percentage of participants
Interval 0.3 to 2.8
|
Adverse Events
Enzalutamide 160 mg
Serious events: 193 serious events
Other events: 318 other events
Deaths: 62 deaths
Serious adverse events
| Measure |
Enzalutamide 160 mg
n=423 participants at risk
Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
9/423 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Angina pectoris
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.95%
4/423 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Atrial flutter
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Atrioventricular block complete
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Cardiac failure
|
0.95%
4/423 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.71%
3/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Cardiogenic shock
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Coronary artery disease
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
5/423 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Right ventricular failure
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.24%
1/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Eye disorders
Blindness
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Eye disorders
Eye pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Eye disorders
Vision blurred
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
6/423 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Constipation
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Ileus
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.47%
2/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Nausea
|
0.95%
4/423 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Proctalgia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
7/423 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Asthenia
|
0.71%
3/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Chest pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Death
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Device leakage
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Drug ineffective
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Fatigue
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Gait disturbance
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
General physical health deterioration
|
2.4%
10/423 • Number of events 18 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Glassy eyes
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Multi-organ failure
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Pain
|
1.2%
5/423 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Performance status decreased
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Pyrexia
|
1.9%
8/423 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Spinal pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Sudden cardiac death
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Anal abscess
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Appendicitis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Bacteraemia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Bronchopneumonia
|
0.47%
2/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Candiduria
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Cellulitis
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Corona virus infection
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Cystitis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Diverticulitis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Enterocolitis infectious
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Erysipelas
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Localised infection
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Lung infection
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Pneumonia
|
3.1%
13/423 • Number of events 16 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Pyelonephritis
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Pyelonephritis acute
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Sepsis
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Spinal cord infection
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Tracheobronchitis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Urinary tract infection
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Infections and infestations
Urosepsis
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
10/423 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.47%
2/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Investigations
C-reactive protein increased
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Investigations
Cystoscopy
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Investigations
Haemoglobin decreased
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Investigations
Prostatic specific antigen increased
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
5/423 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
6/423 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
8/423 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.47%
2/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.71%
3/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of ureter
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.0%
34/423 • Number of events 39 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Altered state of consciousness
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Brain stem stroke
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Carotid artery stenosis
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.24%
1/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.47%
2/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Cognitive disorder
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Convulsion
|
1.9%
8/423 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Diplegia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Dysgeusia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Epilepsy
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Grand mal convulsion
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Lethargy
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Loss of consciousness
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Nerve root compression
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Parkinson's disease
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Presyncope
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Somnolence
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Spinal cord compression
|
1.7%
7/423 • Number of events 8 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Syncope
|
1.2%
5/423 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Transient global amnesia
|
0.47%
2/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Agitation
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Confusional state
|
2.4%
10/423 • Number of events 10 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Delirium
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Disorientation
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Fear of falling
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Mental status changes
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Panic attack
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Paranoia
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Anuria
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Bladder dilatation
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Dysuria
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Haematuria
|
1.9%
8/423 • Number of events 12 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Renal failure
|
0.95%
4/423 • Number of events 4 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Renal failure acute
|
0.95%
4/423 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Urethral stenosis
|
0.47%
2/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.24%
1/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
5/423 • Number of events 7 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
5/423 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.71%
3/423 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.95%
4/423 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Surgical and medical procedures
Bladder lesion excision
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Vascular disorders
Aortic aneurysm
|
0.24%
1/423 • Number of events 1 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Vascular disorders
Hypertension
|
0.47%
2/423 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
Other adverse events
| Measure |
Enzalutamide 160 mg
n=423 participants at risk
Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
53/423 • Number of events 82 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Constipation
|
10.9%
46/423 • Number of events 50 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
43/423 • Number of events 54 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Nausea
|
13.0%
55/423 • Number of events 65 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
24/423 • Number of events 29 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Asthenia
|
20.3%
86/423 • Number of events 113 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Fatigue
|
21.7%
92/423 • Number of events 120 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Oedema peripheral
|
7.8%
33/423 • Number of events 39 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
General disorders
Pain
|
5.4%
23/423 • Number of events 28 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
24/423 • Number of events 31 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Investigations
Weight decreased
|
6.1%
26/423 • Number of events 27 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
77/423 • Number of events 92 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
47/423 • Number of events 56 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.1%
68/423 • Number of events 82 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
22/423 • Number of events 24 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
27/423 • Number of events 33 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Nervous system disorders
Headache
|
5.9%
25/423 • Number of events 26 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Psychiatric disorders
Insomnia
|
6.4%
27/423 • Number of events 34 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
33/423 • Number of events 37 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Vascular disorders
Hot flush
|
5.7%
24/423 • Number of events 26 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
|
Vascular disorders
Hypertension
|
7.3%
31/423 • Number of events 36 • From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER