Trial Outcomes & Findings for A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy (NCT NCT01695135)
NCT ID: NCT01695135
Last Updated: 2019-07-18
Results Overview
Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (\>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
Up to 1.8 years
Results posted on
2019-07-18
Participant Flow
A total of 214 participants were enrolled in the study (143 participants in abiraterone acetate group and 71 participants in placebo group).
Participant milestones
| Measure |
Placebo + Prednisone (Double-blind [DB])
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Placebo + Prednisone (DB) to AA + Prednisone (Open-label)
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
AA + Prednisone to AA + Prednisone (Open-label)
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
|---|---|---|---|---|
|
Double-blind Treatment Phase
STARTED
|
71
|
143
|
0
|
0
|
|
Double-blind Treatment Phase
COMPLETED
|
0
|
4
|
0
|
0
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
71
|
139
|
0
|
0
|
|
Open Label Extension Treatment Phase
STARTED
|
0
|
0
|
49
|
80
|
|
Open Label Extension Treatment Phase
COMPLETED
|
0
|
0
|
9
|
10
|
|
Open Label Extension Treatment Phase
NOT COMPLETED
|
0
|
0
|
40
|
70
|
Reasons for withdrawal
| Measure |
Placebo + Prednisone (Double-blind [DB])
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Placebo + Prednisone (DB) to AA + Prednisone (Open-label)
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
AA + Prednisone to AA + Prednisone (Open-label)
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
|---|---|---|---|---|
|
Double-blind Treatment Phase
Progressive disease
|
50
|
110
|
0
|
0
|
|
Double-blind Treatment Phase
Withdrawal by Subject
|
6
|
14
|
0
|
0
|
|
Double-blind Treatment Phase
Adverse Event
|
7
|
7
|
0
|
0
|
|
Double-blind Treatment Phase
Other
|
1
|
3
|
0
|
0
|
|
Double-blind Treatment Phase
Physician Decision
|
6
|
3
|
0
|
0
|
|
Double-blind Treatment Phase
Death
|
1
|
1
|
0
|
0
|
|
Double-blind Treatment Phase
Noncompliance with study drug
|
0
|
1
|
0
|
0
|
|
Open Label Extension Treatment Phase
Progressive disease
|
0
|
0
|
13
|
22
|
|
Open Label Extension Treatment Phase
Withdrawal by Subject
|
0
|
0
|
6
|
16
|
|
Open Label Extension Treatment Phase
Adverse Event
|
0
|
0
|
11
|
16
|
|
Open Label Extension Treatment Phase
Other
|
0
|
0
|
4
|
7
|
|
Open Label Extension Treatment Phase
Physician Decision
|
0
|
0
|
4
|
1
|
|
Open Label Extension Treatment Phase
Death
|
0
|
0
|
2
|
7
|
|
Open Label Extension Treatment Phase
Noncompliance with study drug
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Placebo + Prednisone (Double-blind)
n=71 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
68 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
71 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
71 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1.8 yearsPopulation: Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (\>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=71 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Time to Prostate-Specific Antigen Progression (PSA)
|
84.00 Days
Interval 31.0 to 113.0
|
169.00 Days
Interval 141.0 to 197.0
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (up to approximately 3.8 years)Population: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=71 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Overall Survival
|
561.00 Days
Interval 352.0 to 787.0
|
579.00 Days
Interval 504.0 to 731.0
|
SECONDARY outcome
Timeframe: Approximately up to 3.8 yearsPopulation: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Percentage of participants who achieved PSA response (defined as \>= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: \>= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: \>=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: \>=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=71 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Percentage of Participants Who Achieved PSA Response
|
18.3 Percentage of Participants
|
54.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Approximately up to 3.8 yearsPopulation: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants with measurable disease at baseline.
ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=24 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=57 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Objective Response Rate (ORR)
|
4.2 Percentage of Participants
|
17.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])Population: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=52 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=97 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Functional Well-being
|
-5.1 Units on a scale
Standard Deviation 6.60
|
-2.7 Units on a scale
Standard Deviation 7.31
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Total Score
|
-19.9 Units on a scale
Standard Deviation 22.07
|
-16.1 Units on a scale
Standard Deviation 22.74
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Physical Well-being
|
-6.7 Units on a scale
Standard Deviation 6.52
|
-4.9 Units on a scale
Standard Deviation 6.85
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Emotional Well-being
|
-2.1 Units on a scale
Standard Deviation 4.48
|
-2.4 Units on a scale
Standard Deviation 4.87
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Social Well-being
|
-0.8 Units on a scale
Standard Deviation 3.82
|
-1.2 Units on a scale
Standard Deviation 6.55
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
FACT-G Total Score
|
-14.6 Units on a scale
Standard Deviation 16.25
|
-11.2 Units on a scale
Standard Deviation 17.19
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Prostate Cancer Subscale (PCS)
|
-5.3 Units on a scale
Standard Deviation 7.99
|
-4.9 Units on a scale
Standard Deviation 7.70
|
|
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
Treatment Outcome Index (FACT-TOI)
|
-17.1 Units on a scale
Standard Deviation 17.76
|
-12.5 Units on a scale
Standard Deviation 17.52
|
SECONDARY outcome
Timeframe: Approximately up to 3.8 yearsPopulation: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.
Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of \>=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score \>=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=71 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Time to Pain Progression
|
169.00 Days
Interval 85.0 to 253.0
|
505.00 Days
Interval 365.0 to
Here 'NA' represents that upper limit of Confidence Interval (CI) was not estimable due to lesser number of events.
|
SECONDARY outcome
Timeframe: Approximately up to 3.8 yearsPopulation: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants whose pain score was \>= 4 at baseline.
Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced \>=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=22 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=55 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Percentage of Participants Experiencing Pain Palliation
|
31.8 Percentage of Participants
|
54.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])Population: ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).
Outcome measures
| Measure |
Placebo + Prednisone (Double-blind)
n=52 Participants
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=98 Participants
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
|---|---|---|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Fatigue Now
|
2.4 Units on a scale
Standard Deviation 3.59
|
1.7 Units on a scale
Standard Deviation 3.34
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Usual Fatigue
|
2.4 Units on a scale
Standard Deviation 3.53
|
1.5 Units on a scale
Standard Deviation 3.18
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Worst Fatigue
|
2.6 Units on a scale
Standard Deviation 3.73
|
1.6 Units on a scale
Standard Deviation 3.49
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
General Activity
|
2.3 Units on a scale
Standard Deviation 3.65
|
1.7 Units on a scale
Standard Deviation 3.38
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Mood
|
2.7 Units on a scale
Standard Deviation 3.39
|
1.8 Units on a scale
Standard Deviation 3.40
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Walking Ability
|
2.4 Units on a scale
Standard Deviation 3.28
|
1.8 Units on a scale
Standard Deviation 3.50
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Normal Work
|
2.2 Units on a scale
Standard Deviation 3.84
|
2.0 Units on a scale
Standard Deviation 3.71
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Relations with Other People
|
2.0 Units on a scale
Standard Deviation 3.08
|
1.6 Units on a scale
Standard Deviation 3.25
|
|
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
Enjoyment of Life
|
2.5 Units on a scale
Standard Deviation 3.33
|
1.9 Units on a scale
Standard Deviation 3.64
|
Adverse Events
Placebo + Prednisone (Double-blind)
Serious events: 20 serious events
Other events: 62 other events
Deaths: 0 deaths
Abiraterone Acetate + Prednisone (Double-blind)
Serious events: 33 serious events
Other events: 134 other events
Deaths: 0 deaths
Placebo + Prednisone (DB) to AA + Prednisone (Open-label)
Serious events: 25 serious events
Other events: 35 other events
Deaths: 0 deaths
AA + Prednisone to AA + Prednisone (Open-label)
Serious events: 41 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Prednisone (Double-blind)
n=71 participants at risk
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 participants at risk
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Placebo + Prednisone (DB) to AA + Prednisone (Open-label)
n=49 participants at risk
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
AA + Prednisone to AA + Prednisone (Open-label)
n=80 participants at risk
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
|---|---|---|---|---|
|
General disorders
Disease progression
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.2%
6/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
16.3%
8/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
21.2%
17/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Chest discomfort
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Multi-organ failure
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Oedema peripheral
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Pyrexia
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Death
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.5%
2/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Pain
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Sudden death
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Lung infection
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.4%
2/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Septic shock
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.8%
2/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.1%
3/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.1%
3/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.2%
5/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Nervous system disorders
Cerebral infarction
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Nervous system disorders
Spinal cord compression
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Nervous system disorders
Coma
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.4%
2/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Haemorrhagic infarction
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Eye disorders
Blindness
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Eye disorders
Cataract
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Platelet count decreased
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.5%
2/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
2/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.5%
2/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
Other adverse events
| Measure |
Placebo + Prednisone (Double-blind)
n=71 participants at risk
Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Abiraterone Acetate + Prednisone (Double-blind)
n=143 participants at risk
Participants received abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.
|
Placebo + Prednisone (DB) to AA + Prednisone (Open-label)
n=49 participants at risk
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
AA + Prednisone to AA + Prednisone (Open-label)
n=80 participants at risk
Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.1%
15/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
25.2%
36/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
12.2%
6/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.7%
9/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
14.0%
20/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
10.2%
5/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
11.9%
17/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.5%
11/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
11.9%
17/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
7.0%
10/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
16.9%
12/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
20.3%
29/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
14.3%
7/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
11.2%
9/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
12.7%
9/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
14.0%
20/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
12.2%
6/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.2%
5/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.5%
6/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
7.0%
10/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Blood albumin decreased
|
5.6%
4/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.6%
8/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.5%
2/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Weight decreased
|
4.2%
3/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.6%
8/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
11.2%
9/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.5%
6/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.2%
6/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Platelet count decreased
|
2.8%
2/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.2%
6/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.2%
4/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
7.5%
6/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
White blood cell count decreased
|
4.2%
3/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.1%
3/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.2%
4/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.4%
2/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.4%
2/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.8%
7/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.1%
10/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
27.3%
39/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
16.3%
8/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
17.5%
14/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.5%
6/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
11.9%
17/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.2%
4/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
7.5%
6/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.7%
9/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.1%
3/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.2%
4/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.5%
2/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.5%
6/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.1%
3/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.5%
16/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
26.6%
38/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
26.5%
13/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
36.2%
29/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Fatigue
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
9.1%
13/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Pyrexia
|
4.2%
3/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.4%
12/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.2%
5/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Oedema peripheral
|
12.7%
9/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
7.0%
10/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.2%
5/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
General disorders
Pain
|
5.6%
4/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.70%
1/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Vascular disorders
Hypertension
|
12.7%
9/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
15.4%
22/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
8.5%
6/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
9.1%
13/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
12.2%
6/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.8%
7/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
7.0%
10/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.2%
4/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.4%
12/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.5%
5/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.0%
1/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
5.0%
4/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
6/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.8%
4/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.8%
3/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
4/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.3%
9/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.1%
2/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
7.0%
5/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.3%
9/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
3/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.3%
9/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
1.2%
1/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
2/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
4.9%
7/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
6.1%
3/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
0.00%
0/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.4%
1/71 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
3.5%
5/143 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
8.2%
4/49 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
2.5%
2/80 • Approximately up to 3.8 years
Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER