Trial Outcomes & Findings for A Study to Evaluate Enzalutamide After Abiraterone in Metastatic Castration-Resistant Prostate Cancer (NCT NCT02116582)
NCT ID: NCT02116582
Last Updated: 2024-12-06
Results Overview
Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer \& Crowley (BC) method.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
215 participants
Primary outcome timeframe
From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.
Results posted on
2024-12-06
Participant Flow
Male participants with progressive metastatic castration-resistant prostate cancer were enrolled in this study.
A total of 272 participants were screened for enrollment \& signed an informed consent form, \& 57 of those screen failed. The primary reason for screening failure was not fulfilling inclusion/exclusion criteria (52 participants, 19.1%), followed by withdrawal (5 participants, 1.8%).
Participant milestones
| Measure |
Enzalutamide
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Overall Study
STARTED
|
215
|
|
Overall Study
Treated
|
214
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
215
|
Reasons for withdrawal
| Measure |
Enzalutamide
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Overall Study
Enrolled but Never Received Study Drug
|
1
|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Death
|
9
|
|
Overall Study
Progressive Disease
|
148
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Other: Miscellaneous
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other: Transitioned to 9785-CL-0123
|
12
|
Baseline Characteristics
A Study to Evaluate Enzalutamide After Abiraterone in Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=215 Participants
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Age, Continuous
|
73.2 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
215 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
165 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.Population: The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who took at least 1 dose of study drug.
Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer \& Crowley (BC) method.
Outcome measures
| Measure |
Enzalutamide
n=214 Participants
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Radiographic Progression-free Survival (rPFS)
|
8.1 Months
Interval 6.11 to 8.28
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.Population: The analysis population consisted of the SAF.
OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method.
Outcome measures
| Measure |
Enzalutamide
n=214 Participants
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 18.14 to
Could not be estimated due to the low number of events.
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months.Population: The analysis population consisted of the SAF.
PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution.
Outcome measures
| Measure |
Enzalutamide
n=214 Participants
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Percentage of Participants With a Prostate-specific Antigen (PSA) Response
|
22.0 Percentage of participants
Interval 16.61 to 28.11
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.Population: The analysis population consisted of the SAF.
The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BC method.
Outcome measures
| Measure |
Enzalutamide
n=214 Participants
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Time to PSA Progression
|
5.7 Months
Interval 5.55 to 5.78
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.Population: The analysis population consisted of the SAF.
A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).
Outcome measures
| Measure |
Enzalutamide
n=214 Participants
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Serious Adverse Event (SAE)
|
82 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE
|
199 Participants
|
|
Number of Participants With Adverse Events (AEs)
NCI-CTCAE Grade ≥3
|
95 Participants
|
|
Number of Participants With Adverse Events (AEs)
Study Drug-Related
|
127 Participants
|
|
Number of Participants With Adverse Events (AEs)
Study Drug-Related NCI-CTCAE Grade ≥3
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs with Death as an Outcome
|
22 Participants
|
|
Number of Participants With Adverse Events (AEs)
Study Drug-related SAE
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs Leading to Study Drug Discontinuation
|
76 Participants
|
|
Number of Participants With Adverse Events (AEs)
Study Drug-Related TEAEs Leading to Drug Disc.
|
23 Participants
|
Adverse Events
Enzalutamide Total
Serious events: 82 serious events
Other events: 182 other events
Deaths: 73 deaths
Serious adverse events
| Measure |
Enzalutamide Total
n=214 participants at risk
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
5/214 • Number of events 6 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.93%
2/214 • Number of events 6 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
3/214 • Number of events 3 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Ileus
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Vomiting
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Asthenia
|
1.4%
3/214 • Number of events 3 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Death
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Device occlusion
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
General physical health deterioration
|
4.7%
10/214 • Number of events 13 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Inflammation
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Malaise
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Pain
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Pyrexia
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Bronchopneumonia
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Cellulitis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Dental fistula
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Device related infection
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Enterobacter sepsis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Erysipelas
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Gastroenteritis viral
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.93%
2/214 • Number of events 4 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Pneumonia
|
1.9%
4/214 • Number of events 4 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Pulmonary sepsis
|
0.47%
1/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Pyelonephritis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.47%
1/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Investigations
Monoclonal immunoglobulin present
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/214 • Number of events 4 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
4/214 • Number of events 4 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.1%
13/214 • Number of events 15 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm benign
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Aphasia
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Cerebral infarction
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Encephalitis
|
0.47%
1/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Loss of consciousness
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Monoparesis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Nerve root compression
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Spinal cord compression
|
3.3%
7/214 • Number of events 8 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Syncope
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Vertebral artery thrombosis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Psychiatric disorders
Anxiety
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Psychiatric disorders
Confusional state
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Psychiatric disorders
Disorientation
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Haematuria
|
3.3%
7/214 • Number of events 8 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Renal colic
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Renal failure
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
5/214 • Number of events 8 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.47%
1/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Urinary retention
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/214 • Number of events 4 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic mass
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.93%
2/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
5/214 • Number of events 5 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Surgical and medical procedures
Ileostomy closure
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.47%
1/214 • Number of events 1 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.47%
1/214 • Number of events 2 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
Other adverse events
| Measure |
Enzalutamide Total
n=214 participants at risk
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.7%
23/214 • Number of events 36 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Constipation
|
13.1%
28/214 • Number of events 32 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.6%
27/214 • Number of events 29 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
32/214 • Number of events 38 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
11/214 • Number of events 17 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Asthenia
|
17.8%
38/214 • Number of events 51 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Fatigue
|
33.6%
72/214 • Number of events 89 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Oedema peripheral
|
8.4%
18/214 • Number of events 19 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Investigations
Weight decreased
|
12.1%
26/214 • Number of events 28 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.8%
53/214 • Number of events 65 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
34/214 • Number of events 40 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.3%
37/214 • Number of events 41 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.6%
27/214 • Number of events 34 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
12/214 • Number of events 16 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.7%
23/214 • Number of events 25 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.7%
25/214 • Number of events 29 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Dizziness
|
6.5%
14/214 • Number of events 14 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Psychiatric disorders
Insomnia
|
5.6%
12/214 • Number of events 12 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Haematuria
|
7.0%
15/214 • Number of events 18 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
11/214 • Number of events 12 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Vascular disorders
Hot flush
|
5.6%
12/214 • Number of events 12 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Vascular disorders
Hypertension
|
8.9%
19/214 • Number of events 22 • From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
Additional Information
Executive Medical Director
Astellas Pharma Europe B.V.
Phone: +31 (0) 71 5455 050
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