Trial Outcomes & Findings for A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients (NCT NCT01650194)
NCT ID: NCT01650194
Last Updated: 2024-12-10
Results Overview
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).
COMPLETED
PHASE2
60 participants
From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
2024-12-10
Participant Flow
All participants in this all male study were enrolled at 1 site in the United States (US).
All eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. A total of 64 participants were screened for eligibility.
Participant milestones
| Measure |
Enzalutamide + Abiraterone + Prednisone
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Treated
|
60
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Enzalutamide + Abiraterone + Prednisone
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Overall Study
Progressive Disease (PD)
|
35
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Miscellaneous
|
10
|
Baseline Characteristics
A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=60 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 9.37 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
57 Participants
n=99 Participants
|
|
Ethnicity
Hispanic or Latino
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.Population: The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who received at least 1 dose of any drug of the study combination treatment (i.e., enzalutamide, abiraterone and prednisone).
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 + Abiraterone + Prednisone
n=60 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
TEAEs leading to discontinuation of enzalutamide
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Abiraterone-related TEAEs leading to disc. of abi
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE
|
60 Participants
|
|
Number of Participants With Adverse Events (AEs)
Enzalutamide-related TEAEs
|
56 Participants
|
|
Number of Participants With Adverse Events (AEs)
Abiraterone-related TEAEs
|
58 Participants
|
|
Number of Participants With Adverse Events (AEs)
Prednisone-related TEAEs
|
16 Participants
|
|
Number of Participants With Adverse Events (AEs)
Deaths
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious TEAEs
|
10 Participants
|
|
Number of Participants With Adverse Events (AEs)
Enzalutamide-related serious TEAEs
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Abiraterone-related serious TEAEs
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Prednisone-related serious TEAEs
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Enza-related TEAEs leading to disc. of enza
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Abiraterone-related TEAEs leading to disc. of enza
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Prednisone-related TEAEs leading to disc. of enza
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs leading to discontinuation of abiraterone
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the biomarker testosterone evaluable set (BTES) which consisted of all participants from the SAF with baseline and week 9 testosterone laboratory results derived from bone marrow samples.
Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=45 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate
|
-19.48 pmol/L
Standard Deviation 257.923
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: DHT bone data were not collected.
DHT concentration in bone marrow aspirate was to be measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. DHT bone data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the biomarker cortisol evaluable set (BCES) which consisted of all participants from the SAF with baseline and week 9 cortisol laboratory results derived from bone marrow samples.
Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=47 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Cortisol in Bone Marrow Aspirate
|
-46.86 nmol/L
Standard Deviation 48.022
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the biomarker androstenedione evaluable set (BAOS) which consisted of all participants from the SAF with baseline and week 9 androstenedione laboratory results derived from bone marrow samples.
Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=37 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Androstenedione in Bone Marrow Aspirate
|
-0.32 nmol/L
Standard Deviation 0.342
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the biomarker progesterone evaluable set (BOES) which consisted of all participants from the SAF with baseline and week 9 progesterone laboratory results derived from bone marrow samples.
Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=41 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Progesterone in Bone Marrow Aspirate
|
1.16 nmol/L
Standard Deviation 1.104
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the biomarker pregnenolone evaluable set (BEES) which consisted of all participants from the SAF with baseline and week 9 pregnenolone laboratory results derived from bone marrow samples.
Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=42 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Pregnenolone in Bone Marrow Aspirate
|
1381.44 pg/ml
Standard Deviation 1513.324
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the plasma testosterone evaluable set (PTES) which consisted of all participants from the SAF with baseline and week 9 testosterone laboratory results derived from plasma samples.
Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=49 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Testosterone Concentration in Blood
|
-0.06 nmol/L
Standard Deviation 0.068
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The endpoint could not be analyzed since no participants had DHT levels over the LLOQ.
DHT concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. The endpoint could not be analyzed since no participants had DHT levels over the lower limit of quantification (LLOQ).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the plasma cortisol evaluable set (PCES) which consisted of all participants from the SAF with baseline and week 9 cortisol laboratory results derived from plasma samples.
Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=52 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Cortisol Concentration in Blood
|
-48.81 nmol/L
Standard Deviation 43.725
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the plasma androstenedione evaluable set (PAOS) which consisted of all participants from the SAF with baseline and week 9 androstenedione laboratory results derived from plasma samples.
Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=37 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Androstenedione Concentration in Blood
|
-0.24 nmol/L
Standard Deviation 0.206
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the plasma progesterone evaluable set (POES) which consisted of all participants from the SAF with baseline and week 9 progesterone laboratory results derived from plasma samples.
Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=48 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Progesterone Concentration in Blood
|
1.43 nmol/L
Standard Deviation 2.434
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the plasma pregnenolone evaluable set (PEES) which consisted of all participants from the SAF with baseline and week 9 pregnenolone laboratory results derived from plasma samples.
Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=47 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Pregnenolone Concentration in Blood
|
1507.42 pg/ml
Standard Deviation 1699.335
|
SECONDARY outcome
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.Population: The analysis population consisted of the SAF (participants with available data).
Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=59 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels
|
36.35 ug/L
Standard Deviation 444.355
|
SECONDARY outcome
Timeframe: Up to 1849 daysPopulation: The analysis population consisted of the SAF.
PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=60 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Progression Free Survival (PFS)
|
251 days
Interval 147.0 to 337.0
|
SECONDARY outcome
Timeframe: Up to 1849 daysPopulation: The analysis population consisted of the SAF (participants with measurable soft tissue disease per RECIST 1.1 at baseline with available data).
Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson).
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=16 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST)
|
68.8 percentage of participants
Interval 41.3 to 89.0
|
SECONDARY outcome
Timeframe: EoT; the median duration of treatment was 10.1 months.Population: The analysis population consisted of the SAF (participants with available data).
PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=52 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Bone Scan Response at EoT
Complete Response (CR)
|
1 Participants
|
|
Bone Scan Response at EoT
Progressive Disease (PD)
|
15 Participants
|
|
Bone Scan Response at EoT
Non-CR/Non-PD
|
35 Participants
|
|
Bone Scan Response at EoT
Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.Population: The analysis population consisted of the SAF (participants with available data).
Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=49 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline to EoT in Bone Specific Alkaline Phosphatase
|
-5.18 ug/L
Standard Deviation 43.626
|
SECONDARY outcome
Timeframe: Baseline and Week 9Population: The analysis population consisted of the SAF (participants with available data).
Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected.
Outcome measures
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=34 Participants
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Change From Baseline in Urine N-Telopeptide
|
29.35 nmolBCE/mmolcreat
Standard Deviation 85.927
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 9Population: Data for these endpoints were not collected.
The endpoint was considered exploratory and no analysis was planned.
Outcome measures
Outcome data not reported
Adverse Events
Enzalutamide + Abiraterone + Prednisone
Serious adverse events
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=60 participants at risk
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Eye disorders
Macular oedema
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Eye disorders
Retinal vein occlusion
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Infections and infestations
Urosepsis
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Spinal cord compression
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Number of events 1 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
Other adverse events
| Measure |
Enzalutamide + Abiraterone + Prednisone
n=60 participants at risk
Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.0%
21/60 • Number of events 40 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
6/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
5/60 • Number of events 5 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Gastrointestinal disorders
Constipation
|
11.7%
7/60 • Number of events 10 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
9/60 • Number of events 14 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Gastrointestinal disorders
Nausea
|
23.3%
14/60 • Number of events 28 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
6/60 • Number of events 20 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
General disorders
Asthenia
|
6.7%
4/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
General disorders
Fatigue
|
71.7%
43/60 • Number of events 62 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
General disorders
Influenza like illness
|
5.0%
3/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
General disorders
Oedema peripheral
|
15.0%
9/60 • Number of events 13 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
General disorders
Pyrexia
|
11.7%
7/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Infections and infestations
Herpes zoster
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Infections and infestations
Sinusitis
|
5.0%
3/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Injury, poisoning and procedural complications
Fall
|
15.0%
9/60 • Number of events 12 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Injury, poisoning and procedural complications
Joint injury
|
5.0%
3/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
13.3%
8/60 • Number of events 10 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
18/60 • Number of events 70 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Aspartate aminotransferase increased
|
36.7%
22/60 • Number of events 54 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood albumin decreased
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
53.3%
32/60 • Number of events 64 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood bilirubin increased
|
20.0%
12/60 • Number of events 26 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood creatinine increased
|
5.0%
3/60 • Number of events 5 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood glucose increased
|
8.3%
5/60 • Number of events 7 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood magnesium decreased
|
10.0%
6/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Blood potassium decreased
|
6.7%
4/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
6/60 • Number of events 12 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Neutrophil count decreased
|
11.7%
7/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
Platelet count decreased
|
11.7%
7/60 • Number of events 12 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Investigations
White blood cell count decreased
|
23.3%
14/60 • Number of events 22 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
8/60 • Number of events 10 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
68.3%
41/60 • Number of events 96 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
11.7%
7/60 • Number of events 10 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
5/60 • Number of events 6 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
6/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
10/60 • Number of events 16 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
12/60 • Number of events 20 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
6/60 • Number of events 7 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.7%
19/60 • Number of events 26 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
20/60 • Number of events 28 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
6/60 • Number of events 19 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
4/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.7%
7/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.0%
9/60 • Number of events 13 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
4/60 • Number of events 8 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
21.7%
13/60 • Number of events 18 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Balance disorder
|
5.0%
3/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Cognitive disorder
|
8.3%
5/60 • Number of events 5 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Dizziness
|
6.7%
4/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Dysgeusia
|
13.3%
8/60 • Number of events 9 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Headache
|
18.3%
11/60 • Number of events 17 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Memory impairment
|
10.0%
6/60 • Number of events 7 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
5/60 • Number of events 5 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
3/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Nervous system disorders
Tremor
|
5.0%
3/60 • Number of events 5 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Psychiatric disorders
Depression
|
6.7%
4/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Psychiatric disorders
Insomnia
|
10.0%
6/60 • Number of events 7 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
10/60 • Number of events 12 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60 • Number of events 11 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
5/60 • Number of events 7 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
4/60 • Number of events 5 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.7%
4/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
9/60 • Number of events 9 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
3/60 • Number of events 4 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
3/60 • Number of events 3 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Vascular disorders
Hot flush
|
45.0%
27/60 • Number of events 39 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
|
Vascular disorders
Hypertension
|
31.7%
19/60 • Number of events 21 • From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc. (APGD)
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