Trial Outcomes & Findings for A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100 (NCT NCT01534052)
NCT ID: NCT01534052
Last Updated: 2024-12-06
Results Overview
An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
Results posted on
2024-12-06
Participant Flow
The study was conducted at 1 site in the Republic of Moldova, 2 sites in South Africa and 4 sites in the United States. In order to participate, participants had to complete a prior study with enzalutamide, be in a state of at least stable disease and benefit from continued treatment with enzalutamide in the opinion of the investigator.
This was an extension study in prostate cancer participants who have received enzalutamide treatment in prior phase 1 studies. The 9785-CL-0121 was an extension of previous enzalutamide studies (9785-CL-0003 \[NCT01902251\], 9785-CL-0007 \[NCT01911728\] \& 9785-CL-0406 \[NCT02225093\]).
Participant milestones
| Measure |
Enzalutamide
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
Treatment Received
|
52
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=52 Participants
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
|
|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 7.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Duration of Prostate Cancer
|
69.4 months
STANDARD_DEVIATION 64.10 • n=5 Participants
|
|
Primary Gleason Score at Initial Diagnosis
Score 3
|
15 Participants
n=5 Participants
|
|
Primary Gleason Score at Initial Diagnosis
Score 4
|
13 Participants
n=5 Participants
|
|
Primary Gleason Score at Initial Diagnosis
Score 5
|
4 Participants
n=5 Participants
|
|
Primary Gleason Score at Initial Diagnosis
Unknown
|
20 Participants
n=5 Participants
|
|
Secondary Gleason Score at Initial Diagnosis
Score 3
|
9 Participants
n=5 Participants
|
|
Secondary Gleason Score at Initial Diagnosis
Score 4
|
14 Participants
n=5 Participants
|
|
Secondary Gleason Score at Initial Diagnosis
Score 5
|
9 Participants
n=5 Participants
|
|
Secondary Gleason Score at Initial Diagnosis
Unknown
|
20 Participants
n=5 Participants
|
|
Total Gleason Score at Initial Diagnosis
Score 6
|
5 Participants
n=5 Participants
|
|
Total Gleason Score at Initial Diagnosis
Score 7
|
16 Participants
n=5 Participants
|
|
Total Gleason Score at Initial Diagnosis
Score 8
|
1 Participants
n=5 Participants
|
|
Total Gleason Score at Initial Diagnosis
Score 9
|
13 Participants
n=5 Participants
|
|
Total Gleason Score at Initial Diagnosis
Unknown
|
17 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
TX - Primary Tumor Cannot be Assessed
|
3 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
T0 - No Evidence of Primary Tumor
|
1 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
T1 - Clinically Tumor Not Palpable or Visible
|
1 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
T2 - Tumor Confined Within the Prostate
|
8 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
T3 - Tumor Extends Through the Prostatic Capsule
|
13 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
T4 - Tumor Fixed or Invades Adjacent Structures
|
3 Participants
n=5 Participants
|
|
Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)
Unknown
|
23 Participants
n=5 Participants
|
|
Pathologic Tumor Stage (pT)
pT2 - Organ Confined
|
5 Participants
n=5 Participants
|
|
Pathologic Tumor Stage (pT)
pT3 - Extraprostatic Extension
|
9 Participants
n=5 Participants
|
|
Pathologic Tumor Stage (pT)
pT4 - Invasion of Bladder, Rectum
|
1 Participants
n=5 Participants
|
|
Pathologic Tumor Stage (pT)
Unknown
|
37 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
NX - Regional Lymph Nodes Were Not Assessed
|
18 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
N0 - No Regional Lymph Node Metastasis
|
15 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
N1 - Metastasis in Regional Lymph Node(s)
|
6 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
pNX - Regional Lymph Nodes Not Sampled
|
8 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
pN0 - No Positive Regional Nodes
|
6 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
pN1 - Metastasis in Regional Nodes(s)
|
2 Participants
n=5 Participants
|
|
Regional Lymph Nodes (N) at Initial Diagnosis
Unknown
|
36 Participants
n=5 Participants
|
|
Distant Metastasis at Initial Diagnosis
MX - Distant Metastasis Cannot be Assessed
|
8 Participants
n=5 Participants
|
|
Distant Metastasis at Initial Diagnosis
M0 - No Distant Metastasis
|
12 Participants
n=5 Participants
|
|
Distant Metastasis at Initial Diagnosis
M1 - Distant Metastasis
|
9 Participants
n=5 Participants
|
|
Distant Metastasis at Initial Diagnosis
Unknown
|
23 Participants
n=5 Participants
|
|
Treatment Duration in Extension Study
<= 60
|
4 Days
n=5 Participants
|
|
Treatment Duration in Extension Study
> 60 - <182
|
12 Days
n=5 Participants
|
|
Treatment Duration in Extension Study
>= 182 - <365
|
9 Days
n=5 Participants
|
|
Treatment Duration in Extension Study
>= 365
|
27 Days
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 daysPopulation: The analysis population was the SAF.
An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.
Outcome measures
| Measure |
Enzalutamide
n=52 Participants
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Any TEAE
|
43 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-Related TEAEs
|
27 Participants
|
|
Number of Participants With Adverse Events (AEs)
Deaths
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious TEAEs
|
17 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-Related Serious TEAEs
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs Leading to Study Drug Discontinuation
|
12 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-Related TEAEs Lead to Study Discontinuation
|
5 Participants
|
Adverse Events
Enzalutimide
Serious events: 17 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Enzalutimide
n=52 participants at risk
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Anal fissure
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Proctalgia
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Asthenia
|
3.8%
2/52 • Number of events 2 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
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
|
7.7%
4/52 • Number of events 4 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Dysarthria
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Hemiparesis
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Spinal cord compression
|
3.8%
2/52 • Number of events 2 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Vascular disorders
Hypertensive crisis
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
Other adverse events
| Measure |
Enzalutimide
n=52 participants at risk
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
4/52 • Number of events 6 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
5/52 • Number of events 7 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52 • Number of events 8 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
3/52 • Number of events 3 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
4/52 • Number of events 4 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52 • Number of events 4 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
General disorders
Fatigue
|
26.9%
14/52 • Number of events 21 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Investigations
Weight decreased
|
7.7%
4/52 • Number of events 4 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.5%
6/52 • Number of events 6 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
4/52 • Number of events 4 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.7%
4/52 • Number of events 9 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.6%
5/52 • Number of events 6 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.7%
4/52 • Number of events 8 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
7/52 • Number of events 7 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
7/52 • Number of events 8 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.8%
3/52 • Number of events 3 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
4/52 • Number of events 7 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
3/52 • Number of events 3 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Number of events 4 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Pollakiuria
|
5.8%
3/52 • Number of events 3 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.8%
3/52 • Number of events 3 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
|
Vascular disorders
Hot flush
|
11.5%
6/52 • Number of events 8 • From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
The total number of deaths (all causes) includes deaths reported after the time frame above.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Europe B.V. (APEB)
Phone: 800-888-7704 Ext:5473
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. The 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