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Trial record 45 of 1543 for:    Androgens

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01715285
Recruitment Status : Active, not recruiting
First Posted : October 26, 2012
Results First Posted : October 15, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Prostate Neoplasms
Interventions Drug: Abiraterone acetate
Drug: Prednisone
Other: Androgen deprivation therapy (ADT)
Drug: Abiraterone acetate Placebo
Drug: Prednisone Placebo
Enrollment 1209
Recruitment Details  
Pre-assignment Details 1209 participants were enrolled and 1199 were randomized to treatment groups.10 participants from Russian site were excluded from the analysis due to noncompliance with International Conference on Harmonisation Good Clinical Practice guidelines at site. The remaining 1199 randomized participants comprised the intent-to-treat population.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT Placebo to Abiraterone Acetate + Prednisone
Hide Arm/Group Description Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered. Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered. Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate + Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Period Title: Treatment Period
Started 597 602 0
ITT Population 597 602 0
Safety Population 597 602 0
Completed 0 0 0
Not Completed 597 602 0
Reason Not Completed
Adverse Event             60             33             0
Lost to Follow-up             3             2             0
Death             36             23             0
Noncompliance With Study Drug             4             2             0
Progressive Disease             254             388             0
Withdrawal Of Consent             52             47             0
Physician Decision             21             23             0
Ongoing             157             0             0
Other             10             12             0
Placebo Cross-over             0             72             0
Period Title: Open-label (OL) Extension Phase
Started 157 0 72
Completed 0 0 0
Not Completed 157 0 72
Reason Not Completed
Ongoing             157             0             72
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT Total
Hide Arm/Group Description Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered. Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered. Total of all reporting groups
Overall Number of Baseline Participants 597 602 1199
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) analysis set included all participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 597 participants 602 participants 1199 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
221
  37.0%
233
  38.7%
454
  37.9%
>=65 years
376
  63.0%
369
  61.3%
745
  62.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 597 participants 602 participants 1199 participants
67.3  (8.48) 66.8  (8.72) 67.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 597 participants 602 participants 1199 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
597
 100.0%
602
 100.0%
1199
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 597 participants 602 participants 1199 participants
Argentina
8
   1.3%
8
   1.3%
16
   1.3%
Australia
4
   0.7%
4
   0.7%
8
   0.7%
Belgium
6
   1.0%
7
   1.2%
13
   1.1%
Brazil
28
   4.7%
28
   4.7%
56
   4.7%
Bulgaria
1
   0.2%
1
   0.2%
2
   0.2%
Canada
16
   2.7%
17
   2.8%
33
   2.8%
Chile
3
   0.5%
4
   0.7%
7
   0.6%
China
69
  11.6%
68
  11.3%
137
  11.4%
Colombia
10
   1.7%
7
   1.2%
17
   1.4%
Czech Republic
9
   1.5%
7
   1.2%
16
   1.3%
Denmark
13
   2.2%
15
   2.5%
28
   2.3%
Finland
4
   0.7%
5
   0.8%
9
   0.8%
France
7
   1.2%
7
   1.2%
14
   1.2%
Germany
4
   0.7%
4
   0.7%
8
   0.7%
Hungary
17
   2.8%
17
   2.8%
34
   2.8%
Israel
14
   2.3%
16
   2.7%
30
   2.5%
Italy
19
   3.2%
20
   3.3%
39
   3.3%
Japan
35
   5.9%
35
   5.8%
70
   5.8%
Malaysia
4
   0.7%
2
   0.3%
6
   0.5%
Mexico
19
   3.2%
19
   3.2%
38
   3.2%
Netherlands
6
   1.0%
4
   0.7%
10
   0.8%
Poland
20
   3.4%
22
   3.7%
42
   3.5%
Portugal
19
   3.2%
20
   3.3%
39
   3.3%
Romania
89
  14.9%
95
  15.8%
184
  15.3%
Russia
89
  14.9%
95
  15.8%
184
  15.3%
Slovakia
17
   2.8%
14
   2.3%
31
   2.6%
South Africa
10
   1.7%
10
   1.7%
20
   1.7%
Korea, Republic Of
16
   2.7%
16
   2.7%
32
   2.7%
Spain
16
   2.7%
17
   2.8%
33
   2.8%
Sweden
11
   1.8%
11
   1.8%
22
   1.8%
Turkey
18
   3.0%
17
   2.8%
35
   2.9%
Ukraine
39
   6.5%
40
   6.6%
79
   6.6%
United Kingdom
18
   3.0%
19
   3.2%
37
   3.1%
New Zealand
6
   1.0%
5
   0.8%
11
   0.9%
1.Primary Outcome
Title Radiographic Progression-Free Survival (PFS)
Hide Description Radiographic PFS was defined as the time interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
Time Frame Up to 44 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: Months
33.02 [1] 
(29.57 to NA)
14.78
(14.69 to 18.27)
[1]
Here ‘NA’ represents that upper limit of CI was not estimable due to lesser number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abiraterone Acetate+Prednisone+ADT, Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.466
Confidence Interval (2-Sided) 95%
0.394 to 0.550
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from randomization to date of death from any cause.
Time Frame Upto 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: months
53.32 [1] 
(48.23 to NA)
36.53
(33.54 to 39.95)
[1]
Here ‘NA’ represents that upper limit of CI was not estimable due to lesser number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abiraterone Acetate+Prednisone+ADT, Placebo + ADT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.661
Confidence Interval (2-Sided) 95%
0.564 to 0.775
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Initiation of Chemotherapy
Hide Description Time to initiation of chemotherapy was defined as the time interval from the date of randomization to the date of initiation of chemotherapy for prostate cancer.
Time Frame Upto 65 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(62.62 to NA)
57.59 [2] 
(38.18 to NA)
[1]
Here, 'NA' indicates that the median and upper limit of CI was not estimated due to lesser number of events.
[2]
Here, 'NA' indicates that the upper limit of CI was not estimated due to lesser number of events.
4.Secondary Outcome
Title Time to Subsequent Therapy for Prostate Cancer
Hide Description Time to subsequent therapy was defined as the time interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.
Time Frame Upto 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: Months
54.87 [1] 
(46.42 to NA)
21.22
(18.56 to 23.49)
[1]
Here 'NA' indicates that the upper limit of CI was not estimated due to lesser number of events.
5.Secondary Outcome
Title Time to Pain Progression
Hide Description Time to pain progression was defined as the time interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
Time Frame Upto 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: Months
47.41 [1] 
(33.15 to NA)
16.62
(11.07 to 23.95)
[1]
Here ‘NA’ represents that upper limit of CI was not estimable due to lesser number of events.
6.Secondary Outcome
Title Time to Skeletal-Related Event
Hide Description Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
Time Frame Upto 44 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Here ‘NA’ represents that median, upper limit and lower limit of CI was not estimable due to lesser number of events.
7.Secondary Outcome
Title Time to Prostate-Specific Antigen (PSA) Progression
Hide Description Time to PSA progression was defined as the time interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
Time Frame Upto 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants randomized into the study.
Arm/Group Title Abiraterone Acetate+Prednisone+ADT Placebo + ADT
Hide Arm/Group Description:
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
Overall Number of Participants Analyzed 597 602
Median (95% Confidence Interval)
Unit of Measure: Months
33.31
(29.44 to 46.09)
7.43
(7.20 to 9.20)
Time Frame Upto 60 months
Adverse Event Reporting Description Safety analysis set included all participants randomized into the study and who received any part of study drug.
 
Arm/Group Title Treatment Period: Abiraterone Acetate+Prednisone+ADT Treatment Period: Placebo + ADT OL Extension Phase: Placebo to Abiraterone Acetate+Prednisone
Hide Arm/Group Description Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered. Participants received placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered. Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate + Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg along with 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
All-Cause Mortality
Treatment Period: Abiraterone Acetate+Prednisone+ADT Treatment Period: Placebo + ADT OL Extension Phase: Placebo to Abiraterone Acetate+Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period: Abiraterone Acetate+Prednisone+ADT Treatment Period: Placebo + ADT OL Extension Phase: Placebo to Abiraterone Acetate+Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   192/597 (32.16%)   151/602 (25.08%)   4/72 (5.56%) 
Blood and lymphatic system disorders       
Anaemia * 1  6/597 (1.01%)  6/602 (1.00%)  1/72 (1.39%) 
Lymphadenitis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Lymphadenopathy * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Neutropenia * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Thrombocytopenia * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Cardiac disorders       
Acute Coronary Syndrome * 1  5/597 (0.84%)  0/602 (0.00%)  0/72 (0.00%) 
Acute Myocardial Infarction * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Angina Pectoris * 1  3/597 (0.50%)  0/602 (0.00%)  0/72 (0.00%) 
Atrial Fibrillation * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Atrial Flutter * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Cardiac Failure * 1  3/597 (0.50%)  0/602 (0.00%)  0/72 (0.00%) 
Cardiac Failure Acute * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Cardiac Failure Chronic * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Coronary Artery Disease * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Mitral Valve Incompetence * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Myocardial Infarction * 1  3/597 (0.50%)  0/602 (0.00%)  0/72 (0.00%) 
Myocardial Ischaemia * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Pericardial Effusion * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Sinus Node Dysfunction * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Congenital, familial and genetic disorders       
Phimosis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Eye disorders       
Cataract * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Glaucoma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Gastrointestinal disorders       
Abdominal Mass * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Abdominal Pain * 1  0/597 (0.00%)  3/602 (0.50%)  0/72 (0.00%) 
Constipation * 1  1/597 (0.17%)  4/602 (0.66%)  0/72 (0.00%) 
Dental Caries * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Duodenal Ulcer * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Duodenitis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Gastric Ulcer * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Gastric Ulcer Perforation * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Gastrointestinal Haemorrhage * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Inguinal Hernia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Intestinal Haemorrhage * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Intestinal Ischaemia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Intestinal Obstruction * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Mouth Haemorrhage * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Nausea * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Peptic Ulcer * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Rectal Haemorrhage * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Vomiting * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Gastritis * 1  0/597 (0.00%)  0/602 (0.00%)  1/72 (1.39%) 
Rectal Polyp * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
General disorders       
Asthenia * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Chest Pain * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
General Physical Health Deterioration * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Hernia Pain * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Multi-Organ Failure * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Non-Cardiac Chest Pain * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Pain * 1  0/597 (0.00%)  3/602 (0.50%)  0/72 (0.00%) 
Peripheral Swelling * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Pyrexia * 1  6/597 (1.01%)  2/602 (0.33%)  0/72 (0.00%) 
Device Dislocation * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Oedema Peripheral * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Hepatobiliary disorders       
Hepatitis Toxic * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Hepatobiliary Disease * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Hepatocellular Injury * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Hypertransaminasaemia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Bile Duct Stone * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Jaundice * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Immune system disorders       
Anaphylactic Reaction * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Infections and infestations       
Appendicitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Bronchitis * 1  4/597 (0.67%)  0/602 (0.00%)  0/72 (0.00%) 
Bronchopneumonia * 1  3/597 (0.50%)  1/602 (0.17%)  0/72 (0.00%) 
Bursitis Infective * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Cellulitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Cellulitis Orbital * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Cystitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Device Related Infection * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Erysipelas * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Eye Infection * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Fungaemia * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Gangrene * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Gastroenteritis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Gastrointestinal Infection * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Herpes Zoster * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Infection * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Lower Respiratory Tract Infection * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Lung Infection * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Nasopharyngitis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Orchitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Osteomyelitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Otitis Media * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Pneumonia * 1  12/597 (2.01%)  2/602 (0.33%)  0/72 (0.00%) 
Pyelonephritis * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Pyelonephritis Acute * 1  1/597 (0.17%)  2/602 (0.33%)  0/72 (0.00%) 
Pyelonephritis Chronic * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Respiratory Tract Infection * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Sepsis * 1  1/597 (0.17%)  2/602 (0.33%)  0/72 (0.00%) 
Spinal Cord Infection * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Staphylococcal Sepsis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Urinary Tract Infection * 1  8/597 (1.34%)  5/602 (0.83%)  0/72 (0.00%) 
Urosepsis * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Localised Infection * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Osteomyelitis Acute * 1  0/597 (0.00%)  0/602 (0.00%)  1/72 (1.39%) 
Sinusitis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Injury, poisoning and procedural complications       
Femoral Neck Fracture * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Femur Fracture * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Fracture * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Head Injury * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Hip Fracture * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Kidney Rupture * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Laceration * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Lower Limb Fracture * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Lumbar Vertebral Fracture * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Patella Fracture * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Pneumothorax Traumatic * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Post Procedural Haematoma * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Procedural Pain * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Pubis Fracture * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Spinal Compression Fracture * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Thermal Burn * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Traumatic Fracture * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Traumatic Intracranial Haemorrhage * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Ligament Sprain * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Upper Limb Fracture * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Investigations       
Alanine Aminotransferase Increased * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Aspartate Aminotransferase Increased * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Biopsy Liver * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Blood Glucose Abnormal * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Blood Testosterone Increased * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Platelet Count Decreased * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Diabetes Mellitus * 1  0/597 (0.00%)  1/602 (0.17%)  1/72 (1.39%) 
Hyperglycaemia * 1  4/597 (0.67%)  1/602 (0.17%)  0/72 (0.00%) 
Hypokalaemia * 1  5/597 (0.84%)  0/602 (0.00%)  0/72 (0.00%) 
Metabolic Syndrome * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  2/597 (0.34%)  4/602 (0.66%)  0/72 (0.00%) 
Back Pain * 1  5/597 (0.84%)  10/602 (1.66%)  0/72 (0.00%) 
Bone Pain * 1  8/597 (1.34%)  6/602 (1.00%)  0/72 (0.00%) 
Gouty Arthritis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Muscular Weakness * 1  2/597 (0.34%)  3/602 (0.50%)  0/72 (0.00%) 
Musculoskeletal Chest Pain * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Musculoskeletal Pain * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Osteoarthritis * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Osteonecrosis of Jaw * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Pain in Extremity * 1  2/597 (0.34%)  2/602 (0.33%)  0/72 (0.00%) 
Pain in Jaw * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Pathological Fracture * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Spinal Column Stenosis * 1  1/597 (0.17%)  2/602 (0.33%)  0/72 (0.00%) 
Spondylitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Trismus * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of Colon * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
B-Cell Lymphoma * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Bladder Neoplasm * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Bladder Transitional Cell Carcinoma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Cancer Pain * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Chronic Lymphocytic Leukaemia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Chronic Myeloid Leukaemia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Colon Neoplasm * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Lentigo Maligna * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Leukaemia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Lung Adenocarcinoma * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Malignant Melanoma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Malignant Neoplasm of Renal Pelvis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Neoplasm Malignant * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Neoplasm of Thymus * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Rectal Cancer * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Transitional Cell Carcinoma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Chronic Lymphocytic Leukaemia Stage 3 * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Colon Cancer * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Metastases to Meninges * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Neuroendocrine Tumour * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Oesophageal Carcinoma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Plasma Cell Myeloma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Metastases to Liver * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Nervous system disorders       
Balance Disorder * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Brain Compression * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Carotid Artery Stenosis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Cerebral Haemorrhage * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Cerebral Infarction * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Cerebral Ischaemia * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Cerebrovascular Accident * 1  2/597 (0.34%)  3/602 (0.50%)  0/72 (0.00%) 
Cognitive Disorder * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Coma * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Dizziness * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Dysarthria * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Epilepsy * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Guillain-Barre Syndrome * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Haemorrhagic Stroke * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Ischaemic Stroke * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Loss of Consciousness * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Myasthenia Gravis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Nerve Compression * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Neuralgia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Optic Nerve Compression * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Paraparesis * 1  0/597 (0.00%)  3/602 (0.50%)  0/72 (0.00%) 
Paraplegia * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Presyncope * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Radiculitis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Sciatica * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Speech Disorder * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Spinal Cord Compression * 1  11/597 (1.84%)  11/602 (1.83%)  0/72 (0.00%) 
Syncope * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Transient Ischaemic Attack * 1  2/597 (0.34%)  1/602 (0.17%)  0/72 (0.00%) 
Vascular Encephalopathy * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Lacunar Infarction * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Ataxia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Psychiatric disorders       
Confusional State * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Mental Disorder * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  1/597 (0.17%)  2/602 (0.33%)  0/72 (0.00%) 
Calculus Bladder * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Calculus Ureteric * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Dysuria * 1  2/597 (0.34%)  2/602 (0.33%)  0/72 (0.00%) 
Haematuria * 1  8/597 (1.34%)  3/602 (0.50%)  0/72 (0.00%) 
Hydronephrosis * 1  2/597 (0.34%)  2/602 (0.33%)  0/72 (0.00%) 
Lower Urinary Tract Symptoms * 1  1/597 (0.17%)  2/602 (0.33%)  0/72 (0.00%) 
Micturition Urgency * 1  0/597 (0.00%)  2/602 (0.33%)  0/72 (0.00%) 
Pollakiuria * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Renal Failure * 1  3/597 (0.50%)  1/602 (0.17%)  0/72 (0.00%) 
Renal Injury * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Ureteric Obstruction * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Urethral Haemorrhage * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Urinary Retention * 1  10/597 (1.68%)  11/602 (1.83%)  0/72 (0.00%) 
Urinary Tract Obstruction * 1  3/597 (0.50%)  3/602 (0.50%)  0/72 (0.00%) 
Bladder Outlet Obstruction * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Chronic Kidney Disease * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Urethral Stenosis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Ureteric Stenosis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Reproductive system and breast disorders       
Pelvic Pain * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Prostatic Haemorrhage * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Prostatitis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Benign Prostatic Hyperplasia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchiectasis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Bronchospasm * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Chronic Obstructive Pulmonary Disease * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Dysphonia * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Dyspnoea * 1  1/597 (0.17%)  3/602 (0.50%)  0/72 (0.00%) 
Epistaxis * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Pleural Effusion * 1  0/597 (0.00%)  4/602 (0.66%)  0/72 (0.00%) 
Pneumonia Aspiration * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Pneumonitis * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Pulmonary Embolism * 1  1/597 (0.17%)  1/602 (0.17%)  0/72 (0.00%) 
Pulmonary Mass * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Pulmonary Oedema * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Respiratory Failure * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Bronchitis Chronic * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Emphysema * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Oropharyngeal Pain * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin Lesion * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Surgical and medical procedures       
Lipoma Excision * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Vascular disorders       
Angiopathy * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Aortic Aneurysm * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Aortic Dissection * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Blood Pressure Fluctuation * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
Deep Vein Thrombosis * 1  4/597 (0.67%)  4/602 (0.66%)  0/72 (0.00%) 
Embolism * 1  0/597 (0.00%)  1/602 (0.17%)  0/72 (0.00%) 
Hypertension * 1  2/597 (0.34%)  2/602 (0.33%)  0/72 (0.00%) 
Hypertensive Crisis * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Intermittent Claudication * 1  2/597 (0.34%)  0/602 (0.00%)  0/72 (0.00%) 
Peripheral Vascular Disorder * 1  1/597 (0.17%)  0/602 (0.00%)  0/72 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Period: Abiraterone Acetate+Prednisone+ADT Treatment Period: Placebo + ADT OL Extension Phase: Placebo to Abiraterone Acetate+Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   533/597 (89.28%)   515/602 (85.55%)   35/72 (48.61%) 
Blood and lymphatic system disorders       
Anaemia * 1  58/597 (9.72%)  89/602 (14.78%)  3/72 (4.17%) 
Gastrointestinal disorders       
Constipation * 1  68/597 (11.39%)  67/602 (11.13%)  2/72 (2.78%) 
Diarrhoea * 1  37/597 (6.20%)  44/602 (7.31%)  0/72 (0.00%) 
Nausea * 1  42/597 (7.04%)  40/602 (6.64%)  1/72 (1.39%) 
Vomiting * 1  39/597 (6.53%)  35/602 (5.81%)  0/72 (0.00%) 
Abdominal Pain * 1  26/597 (4.36%)  31/602 (5.15%)  0/72 (0.00%) 
General disorders       
Fatigue * 1  84/597 (14.07%)  90/602 (14.95%)  1/72 (1.39%) 
Oedema Peripheral * 1  61/597 (10.22%)  55/602 (9.14%)  2/72 (2.78%) 
Asthenia * 1  31/597 (5.19%)  27/602 (4.49%)  0/72 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  47/597 (7.87%)  36/602 (5.98%)  0/72 (0.00%) 
Upper Respiratory Tract Infection * 1  42/597 (7.04%)  29/602 (4.82%)  2/72 (2.78%) 
Urinary Tract Infection * 1  39/597 (6.53%)  20/602 (3.32%)  3/72 (4.17%) 
Influenza * 1  42/597 (7.04%)  20/602 (3.32%)  3/72 (4.17%) 
Investigations       
Alanine Aminotransferase Increased * 1  100/597 (16.75%)  77/602 (12.79%)  5/72 (6.94%) 
Aspartate Aminotransferase Increased * 1  91/597 (15.24%)  68/602 (11.30%)  5/72 (6.94%) 
Blood Lactate Dehydrogenase Increased * 1  40/597 (6.70%)  32/602 (5.32%)  1/72 (1.39%) 
Weight Increased * 1  54/597 (9.05%)  51/602 (8.47%)  0/72 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite * 1  23/597 (3.85%)  33/602 (5.48%)  0/72 (0.00%) 
Hyperglycaemia * 1  83/597 (13.90%)  72/602 (11.96%)  5/72 (6.94%) 
Hypokalaemia * 1  143/597 (23.95%)  23/602 (3.82%)  9/72 (12.50%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  96/597 (16.08%)  86/602 (14.29%)  4/72 (5.56%) 
Back Pain * 1  120/597 (20.10%)  122/602 (20.27%)  5/72 (6.94%) 
Bone Pain * 1  81/597 (13.57%)  90/602 (14.95%)  0/72 (0.00%) 
Musculoskeletal Pain * 1  32/597 (5.36%)  42/602 (6.98%)  2/72 (2.78%) 
Pain in Extremity * 1  72/597 (12.06%)  69/602 (11.46%)  2/72 (2.78%) 
Nervous system disorders       
Headache * 1  46/597 (7.71%)  31/602 (5.15%)  2/72 (2.78%) 
Psychiatric disorders       
Insomnia * 1  32/597 (5.36%)  30/602 (4.98%)  1/72 (1.39%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  41/597 (6.87%)  18/602 (2.99%)  2/72 (2.78%) 
Vascular disorders       
Hot Flush * 1  92/597 (15.41%)  76/602 (12.62%)  1/72 (1.39%) 
Hypertension * 1  229/597 (38.36%)  133/602 (22.09%)  4/72 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Development
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01715285     History of Changes
Other Study ID Numbers: CR100900
212082PCR3011 ( Other Identifier: Janssen Research & Development, LLC )
2012-002940-26 ( EudraCT Number )
U1111-1135-7146 ( Other Identifier: Universal Trial Number )
First Submitted: October 24, 2012
First Posted: October 26, 2012
Results First Submitted: March 9, 2018
Results First Posted: October 15, 2018
Last Update Posted: September 20, 2019