Trial Outcomes & Findings for An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy (NCT NCT00485303)
NCT ID: NCT00485303
Last Updated: 2013-07-02
Results Overview
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
COMPLETED
PHASE2
58 participants
Day 1 of each cycle (of 28 days each) up to Cycle 12
2013-07-02
Participant Flow
Participant milestones
| Measure |
Abiraterone
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
| Measure |
Abiraterone
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Progressive Disease
|
44
|
|
Overall Study
Other
|
3
|
|
Overall Study
Initiation of new anti-cancer treatment
|
2
|
|
Overall Study
Treatment ongoing at cutoff date
|
2
|
Baseline Characteristics
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Age Continuous
|
68.6 Years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of each cycle (of 28 days each) up to Cycle 12Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Prostate Specific Antigen (PSA) Response
|
37.9 percentage of participants
Interval 25.5 to 51.6
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 monthsPopulation: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.
The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group \[PSAWG\] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
|
141 days
Interval 110.0 to 200.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 monthsThe RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Radiographic Progression Free Survival (PFS)
|
126 days
Interval 82.0 to 333.0
|
SECONDARY outcome
Timeframe: Every 3 months until death or up to 60 monthsPopulation: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.
Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (OS)
|
492 days
Interval 373.0 to 647.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 monthsPopulation: Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. "N" (number of participants analyzed) =participants who were evaluable for this measure.
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Abiraterone
n=48 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Objective Radiographic Response
Complete response (CR)
|
0 percentage of participants
|
|
Percentage of Participants With Objective Radiographic Response
Partial Response (PR)
|
6.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)Population: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.
The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Time to PSA Progression
|
169 days
Interval 99.0 to 225.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 monthsPopulation: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.
Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Radiographic Progression
|
88 days
Interval 82.0 to 333.0
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 monthsPopulation: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.
ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair \>50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.
Outcome measures
| Measure |
Abiraterone
n=57 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Best Post-dose:0
|
22 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Best Post-dose:1
|
2 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Best Post-dose:2
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Best Post-dose:3
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Best Post-dose:4
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Best Post-dose:0
|
14 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Best Post-dose:1
|
15 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Best Post-dose:2
|
2 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Best Post-dose:3
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Best Post-dose:4
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Best Post-dose:0
|
1 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Best Post-dose:1
|
1 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Best Post-dose:2
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Best Post-dose:3
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Best Post-dose:4
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Worst Post-dose:0
|
6 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Worst Post-dose:1
|
17 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Worst Post-dose:2
|
1 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Worst Post-dose:3
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:0; Worst Post-dose:4
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Worst Post-dose:0
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Worst Post-dose:1
|
24 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Worst Post-dose:2
|
6 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Worst Post-dose:3
|
1 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:1; Worst Post-dose:4
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Worst Post-dose:0
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Worst Post-dose:1
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Worst Post-dose:2
|
2 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Worst Post-dose:3
|
0 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline:2; Worst Post-dose:4
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 monthsPopulation: Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.
Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.
Outcome measures
| Measure |
Abiraterone
n=58 Participants
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Clinical Benefit
Disease Stabilization
|
12 percentage of participants
|
|
Percentage of Participants With Clinical Benefit
Change in participant ECOG score
|
16 percentage of participants
|
Adverse Events
Abiraterone
Serious adverse events
| Measure |
Abiraterone
n=58 participants at risk
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Renal and urinary disorders
Renal failure
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Reproductive system and breast disorders
Scrotal swelling
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Cardiac disorders
Angina pectoris
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Cardiac disorders
Ventricular tachycardia
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Disease progression
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Fatigue
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Pyrexia
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Infections and infestations
Cellulitis
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Infections and infestations
Pneumonia
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Blood amylase increased
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Blood creatinine increased
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Blood potassium increased
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Haemoglobin decreased
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
White blood cell count decreased
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Nervous system disorders
Dizziness
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Nervous system disorders
Spinal cord compression
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Nervous system disorders
Syncope
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Haematuria
|
3.4%
2/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Vascular disorders
Aortic stenosis
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
|
Vascular disorders
Hypotension
|
1.7%
1/58 • Day 8 of Cycle 1 up to End of Study
|
Other adverse events
| Measure |
Abiraterone
n=58 participants at risk
Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.9%
15/58 • Day 8 of Cycle 1 up to End of Study
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.3%
6/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Constipation
|
25.9%
15/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
10/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Nausea
|
19.0%
11/58 • Day 8 of Cycle 1 up to End of Study
|
|
Gastrointestinal disorders
Vomiting
|
15.5%
9/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Fatigue
|
39.7%
23/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Oedema peripheral
|
31.0%
18/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Pain
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
General disorders
Pyrexia
|
15.5%
9/58 • Day 8 of Cycle 1 up to End of Study
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Infections and infestations
Urinary tract infection
|
10.3%
6/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
6/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Aspartate aminotransferase increased
|
25.9%
15/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Blood albumin decreased
|
20.7%
12/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Blood alkaline phosphatase increased
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Investigations
Weight decreased
|
17.2%
10/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Anorexia
|
13.8%
8/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.7%
12/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.1%
7/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.6%
5/58 • Day 8 of Cycle 1 up to End of Study
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.4%
13/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.9%
15/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.1%
7/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
8.6%
5/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
6/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.3%
6/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.5%
9/58 • Day 8 of Cycle 1 up to End of Study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.5%
9/58 • Day 8 of Cycle 1 up to End of Study
|
|
Nervous system disorders
Headache
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
|
Nervous system disorders
Hypoaesthesia
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.5%
9/58 • Day 8 of Cycle 1 up to End of Study
|
|
Psychiatric disorders
Anxiety
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Psychiatric disorders
Depressed mood
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
|
Psychiatric disorders
Insomnia
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Dysuria
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
8.6%
5/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Micturition urgency
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Nocturia
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Pollakiuria
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Renal and urinary disorders
Urinary incontinence
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
5/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.2%
10/58 • Day 8 of Cycle 1 up to End of Study
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.9%
4/58 • Day 8 of Cycle 1 up to End of Study
|
|
Vascular disorders
Hot flush
|
10.3%
6/58 • Day 8 of Cycle 1 up to End of Study
|
|
Vascular disorders
Hypertension
|
5.2%
3/58 • Day 8 of Cycle 1 up to End of Study
|
Additional Information
Senior Director, Clinical Research
Janssen Research & Development, 10990 Wilshire Blvd, Suite 1200, Los Angeles, California 90024
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60