An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1: AAP and apalutamide Participants will receive apalutamide 240 milligram (mg) (4*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone). |
Drug: Apalutamide
Participants will receive 240 mg (4*60 mg tablets) of apalutamide once daily orally.
Drug: Abiraterone acetate
Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Other Names:
Drug: Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
|
Placebo Comparator: Group 2: AAP and Placebo Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone). |
Drug: Abiraterone acetate
Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Other Names:
Drug: Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
Drug: Placebo
Participants will receive matching placebo to apalutamide once daily orally.
|
Outcome Measures
Primary Outcome Measures
- Radiographic Progression-free Survival (rPFS) [Up to 3 years and 4 months]
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Secondary Outcome Measures
- Overall Survival (OS) [Up to 5 years and 10 months]
The OS was defined as the time from randomization to date of death from any cause.
- Time to Chronic Opioid Use [Up to 5 years and 10 months]
Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use.
- Time to Initiation of Cytotoxic Chemotherapy [Up to 5 years and 10 months]
Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.
- Time to Pain Progression [Up to 5 years and 10 months]
Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.CRF pain refers to participant's response to global pain assessment "How would you rate your pain over the past 7 days?"with a scale of 0("No pain") to 10("Pain as bad as you can imagine"),that is systematically reported and recorded on the eCRF.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adenocarcinoma of the prostate
-
Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter
-
Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)
-
Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
-
Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2
-
Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.
Exclusion Criteria:
-
Small cell or neuroendocrine carcinoma of the prostate
-
Known brain metastases
-
Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
-
Previously treated with ketoconazole for prostate cancer for greater than 7 days
-
Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
-
At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Phoenix | Arizona | United States | ||
2 | La Mesa | California | United States | ||
3 | Los Angeles | California | United States | ||
4 | Modesto | California | United States | ||
5 | San Diego | California | United States | ||
6 | San Francisco | California | United States | ||
7 | Santa Barbara | California | United States | ||
8 | Aurora | Colorado | United States | ||
9 | Denver | Colorado | United States | ||
10 | New Haven | Connecticut | United States | ||
11 | Jensen Beach | Florida | United States | ||
12 | Lakeland | Florida | United States | ||
13 | New Port Richey | Florida | United States | ||
14 | Ocala | Florida | United States | ||
15 | Atlanta | Georgia | United States | ||
16 | Melrose | Illinois | United States | ||
17 | Niles | Illinois | United States | ||
18 | Marrero | Louisiana | United States | ||
19 | New Orleans | Louisiana | United States | ||
20 | Shreveport | Louisiana | United States | ||
21 | Auburn | Maine | United States | ||
22 | Baltimore | Maryland | United States | ||
23 | Boston | Massachusetts | United States | ||
24 | Saint Louis | Missouri | United States | ||
25 | Omaha | Nebraska | United States | ||
26 | Las Vegas | Nevada | United States | ||
27 | Albany | New York | United States | ||
28 | Bronx | New York | United States | ||
29 | Johnson City | New York | United States | ||
30 | New York | New York | United States | ||
31 | Poughkeepsie | New York | United States | ||
32 | Syracuse | New York | United States | ||
33 | Columbus | Ohio | United States | ||
34 | Tualatin | Oregon | United States | ||
35 | Lancaster | Pennsylvania | United States | ||
36 | Pittsburgh | Pennsylvania | United States | ||
37 | Charleston | South Carolina | United States | ||
38 | Myrtle Beach | South Carolina | United States | ||
39 | Nashville | Tennessee | United States | ||
40 | Austin | Texas | United States | ||
41 | Houston | Texas | United States | ||
42 | Norfolk | Virginia | United States | ||
43 | Richmond | Virginia | United States | ||
44 | Auburn | Washington | United States | ||
45 | Seattle | Washington | United States | ||
46 | Spokane | Washington | United States | ||
47 | Wenatchee | Washington | United States | ||
48 | Madison | Wisconsin | United States | ||
49 | Ciudad Automoma Buenos Aires | Argentina | |||
50 | Ciudad de Buenos Aires | Argentina | |||
51 | Cordoba | Argentina | |||
52 | La Rioja | Argentina | |||
53 | Mendoza | Argentina | |||
54 | Rosario | Argentina | |||
55 | Adelaide | Australia | |||
56 | Ashford | Australia | |||
57 | Camperdown | Australia | |||
58 | Herston | Australia | |||
59 | Liverpool | Australia | |||
60 | Malvern | Australia | |||
61 | Melbourne | Australia | |||
62 | Southport | Australia | |||
63 | Wahroonga | Australia | |||
64 | West Heidelberg | Australia | |||
65 | Woolloongabba | Australia | |||
66 | Antwerpen | Belgium | |||
67 | Bruxelles | Belgium | |||
68 | Gent | Belgium | |||
69 | Gosselies | Belgium | |||
70 | Leuven | Belgium | |||
71 | Liege | Belgium | |||
72 | Namur | Belgium | |||
73 | Ottignies | Belgium | |||
74 | Roeselare | Belgium | |||
75 | Sint-Niklaas | Belgium | |||
76 | Barretos | Brazil | |||
77 | IjuĂ | Brazil | |||
78 | Natal | Brazil | |||
79 | Porto Alegre | Brazil | |||
80 | Sao Jose Do Rio Preto | Brazil | |||
81 | Sao Paulo | Brazil | |||
82 | Abbotsford | British Columbia | Canada | ||
83 | Kelowna | British Columbia | Canada | ||
84 | Vancouver | British Columbia | Canada | ||
85 | Halifax | Nova Scotia | Canada | ||
86 | Barrie | Ontario | Canada | ||
87 | London | Ontario | Canada | ||
88 | Oakville | Ontario | Canada | ||
89 | Toronto | Ontario | Canada | ||
90 | Weston | Ontario | Canada | ||
91 | Montreal | Quebec | Canada | ||
92 | Sherbrooke | Quebec | Canada | ||
93 | Quebec | Canada | |||
94 | Toronto | Canada | |||
95 | Angers Cedex 9 | France | |||
96 | Caen Cedex 05 | France | |||
97 | Dijon Cedex | France | |||
98 | Le Mans Cedex 2 | France | |||
99 | Lyon cedex 03 | France | |||
100 | Lyon | France | |||
101 | Montpellier | France | |||
102 | Paris Cedex 15 | France | |||
103 | Saint Herblain | France | |||
104 | Toulouse Cedex 9 | France | |||
105 | Berlin | Germany | |||
106 | Braunschweig | Germany | |||
107 | Dresden | Germany | |||
108 | Frankfurt | Germany | |||
109 | Freiburg | Germany | |||
110 | Hamburg | Germany | |||
111 | Heidelberg | Germany | |||
112 | Muenchen | Germany | |||
113 | Muenster | Germany | |||
114 | Nuertingen | Germany | |||
115 | TĂĽbingen | Germany | |||
116 | Wuppertal | Germany | |||
117 | Fukuoka-shi | Japan | |||
118 | Kanazawa | Japan | |||
119 | Kashiwa | Japan | |||
120 | Kita-Gun | Japan | |||
121 | Kumamoto | Japan | |||
122 | Kurume | Japan | |||
123 | Matsuyama-Shi | Japan | |||
124 | Miyazaki | Japan | |||
125 | Nagasaki | Japan | |||
126 | Osaka-Sayama | Japan | |||
127 | Osaka | Japan | |||
128 | Sakura | Japan | |||
129 | Sapporo | Japan | |||
130 | Ube | Japan | |||
131 | Yokohama | Japan | |||
132 | Goyang-Si | Korea, Republic of | |||
133 | Seongnam | Korea, Republic of | |||
134 | Seoul | Korea, Republic of | |||
135 | Chihuahua | Mexico | |||
136 | Cuernavaca | Mexico | |||
137 | Culiacan | Mexico | |||
138 | Mexico | Mexico | |||
139 | Oaxaca | Mexico | |||
140 | Zapopan | Mexico | |||
141 | Amsterdam Zuidoost | Netherlands | |||
142 | Amsterdam | Netherlands | |||
143 | Blaricum | Netherlands | |||
144 | Den Haag | Netherlands | |||
145 | Dordrecht | Netherlands | |||
146 | Groningen | Netherlands | |||
147 | Heerlen | Netherlands | |||
148 | Nieuwegein | Netherlands | |||
149 | Nijmegen | Netherlands | |||
150 | Rotterdam | Netherlands | |||
151 | Kursk | Russian Federation | |||
152 | Moscow | Russian Federation | |||
153 | Omsk | Russian Federation | |||
154 | Pyatigorsk | Russian Federation | |||
155 | Rostov-on-Don | Russian Federation | |||
156 | Saint Petersburg | Russian Federation | |||
157 | Saint-Petersburg, | Russian Federation | |||
158 | Saint-Petersburg | Russian Federation | |||
159 | Ufa | Russian Federation | |||
160 | Bloemfontein | South Africa | |||
161 | Cape Town | South Africa | |||
162 | Johannesburg | South Africa | |||
163 | Pretoria | South Africa | |||
164 | Alcorcon | Spain | |||
165 | Barcelona | Spain | |||
166 | Cadiz | Spain | |||
167 | Cordoba | Spain | |||
168 | Madrid | Spain | |||
169 | San Sebastián de los Reyes | Spain | |||
170 | Valencia | Spain | |||
171 | Ayr | United Kingdom | |||
172 | Belfast | United Kingdom | |||
173 | Birmingham | United Kingdom | |||
174 | Bristol | United Kingdom | |||
175 | Edinburgh | United Kingdom | |||
176 | Glasgow | United Kingdom | |||
177 | London | United Kingdom | |||
178 | Manchester | United Kingdom | |||
179 | Plymouth | United Kingdom | |||
180 | Preston | United Kingdom | |||
181 | Stevenage | United Kingdom | |||
182 | Sutton | United Kingdom | |||
183 | Westcliff on Sea | United Kingdom | |||
184 | Wirral | United Kingdom |
Sponsors and Collaborators
- Aragon Pharmaceuticals, Inc.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- CR105505
- 56021927PCR3001
- 2014-001718-25
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Treatment disposition has been reported in participant flow. |
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone |
---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. |
Period Title: Overall Study | ||
STARTED | 490 | 492 |
COMPLETED | 39 | 45 |
NOT COMPLETED | 451 | 447 |
Baseline Characteristics
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone | Total |
---|---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Total of all reporting groups |
Overall Participants | 490 | 492 | 982 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
70.7
(8.06)
|
71.4
(8.34)
|
71.1
(8.21)
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
0
0%
|
0
0%
|
Male |
490
100%
|
492
100%
|
982
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
54
11%
|
50
10.2%
|
104
10.6%
|
Not Hispanic or Latino |
411
83.9%
|
422
85.8%
|
833
84.8%
|
Unknown or Not Reported |
25
5.1%
|
20
4.1%
|
45
4.6%
|
Race/Ethnicity, Customized (Count of Participants) | |||
American Indian or Alaska Native |
8
1.6%
|
9
1.8%
|
17
1.7%
|
Asian |
53
10.8%
|
58
11.8%
|
111
11.3%
|
Black or African American |
18
3.7%
|
19
3.9%
|
37
3.8%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
White |
373
76.1%
|
365
74.2%
|
738
75.2%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
20
4.1%
|
20
4.1%
|
40
4.1%
|
Other |
18
3.7%
|
21
4.3%
|
39
4%
|
Region of Enrollment (Count of Participants) | |||
ARGENTINA |
3
0.6%
|
3
0.6%
|
6
0.6%
|
AUSTRALIA |
31
6.3%
|
47
9.6%
|
78
7.9%
|
BELGIUM |
16
3.3%
|
16
3.3%
|
32
3.3%
|
BRAZIL |
21
4.3%
|
18
3.7%
|
39
4%
|
CANADA |
12
2.4%
|
18
3.7%
|
30
3.1%
|
FRANCE |
18
3.7%
|
16
3.3%
|
34
3.5%
|
GERMANY |
10
2%
|
9
1.8%
|
19
1.9%
|
ITALY |
33
6.7%
|
36
7.3%
|
69
7%
|
JAPAN |
23
4.7%
|
27
5.5%
|
50
5.1%
|
MEXICO |
19
3.9%
|
16
3.3%
|
35
3.6%
|
NETHERLANDS |
14
2.9%
|
16
3.3%
|
30
3.1%
|
RUSSIAN FEDERATION |
59
12%
|
46
9.3%
|
105
10.7%
|
SOUTH AFRICA |
9
1.8%
|
8
1.6%
|
17
1.7%
|
SOUTH KOREA |
28
5.7%
|
29
5.9%
|
57
5.8%
|
SPAIN |
43
8.8%
|
36
7.3%
|
79
8%
|
UNITED KINGDOM |
23
4.7%
|
27
5.5%
|
50
5.1%
|
UNITED STATES |
128
26.1%
|
124
25.2%
|
252
25.7%
|
Outcome Measures
Title | Radiographic Progression-free Survival (rPFS) |
---|---|
Description | The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. |
Time Frame | Up to 3 years and 4 months |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. |
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone |
---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. |
Measure Participants | 490 | 492 |
Median (95% Confidence Interval) [months] |
16.59
|
23.98
|
Title | Overall Survival (OS) |
---|---|
Description | The OS was defined as the time from randomization to date of death from any cause. |
Time Frame | Up to 5 years and 10 months |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. |
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone |
---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. |
Measure Participants | 490 | 492 |
Median (95% Confidence Interval) [months] |
33.71
|
36.17
|
Title | Time to Chronic Opioid Use |
---|---|
Description | Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use. |
Time Frame | Up to 5 years and 10 months |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. |
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone |
---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. |
Measure Participants | 490 | 492 |
Median (95% Confidence Interval) [months] |
53.26
|
46.98
|
Title | Time to Initiation of Cytotoxic Chemotherapy |
---|---|
Description | Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy. |
Time Frame | Up to 5 years and 10 months |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. |
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone |
---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. |
Measure Participants | 490 | 492 |
Median (95% Confidence Interval) [months] |
34.23
|
36.11
|
Title | Time to Pain Progression |
---|---|
Description | Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.CRF pain refers to participant's response to global pain assessment "How would you rate your pain over the past 7 days?"with a scale of 0("No pain") to 10("Pain as bad as you can imagine"),that is systematically reported and recorded on the eCRF. |
Time Frame | Up to 5 years and 10 months |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received. |
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone |
---|---|---|
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. |
Measure Participants | 490 | 492 |
Median (95% Confidence Interval) [months] |
26.51
|
21.82
|
Adverse Events
Time Frame | Up to 3 years and 4 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | Safety Analysis set included all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual study treatment received. | |||
Arm/Group Title | Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone | ||
Arm/Group Description | Participants received 4*60 milligrams (mg) tablets of matching placebo orally once daily (qd) with or without food and 4*250 mg tablets of abiraterone acetate (AA) orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles (each cycle was equal to 28 days), and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | Participants received 4*60 mg tablets of apalutamide tablets orally qd with or without food and 4*250 mg tablets of AA orally qd on empty stomach followed by prednisolone 5 mg orally twice daily with food for 24 cycles, and thereafter every 3 cycles. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death. | ||
All Cause Mortality |
||||
Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 350/489 (71.6%) | 338/490 (69%) | ||
Serious Adverse Events |
||||
Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 166/489 (33.9%) | 192/490 (39.2%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 5/489 (1%) | 2/490 (0.4%) | ||
Blood Loss Anaemia | 1/489 (0.2%) | 0/490 (0%) | ||
Disseminated Intravascular Coagulation | 1/489 (0.2%) | 0/490 (0%) | ||
Febrile Neutropenia | 4/489 (0.8%) | 1/490 (0.2%) | ||
Neutropenia | 0/489 (0%) | 1/490 (0.2%) | ||
Thrombocytopenia | 1/489 (0.2%) | 0/490 (0%) | ||
Cardiac disorders | ||||
Acute Left Ventricular Failure | 1/489 (0.2%) | 0/490 (0%) | ||
Acute Myocardial Infarction | 4/489 (0.8%) | 4/490 (0.8%) | ||
Angina Pectoris | 0/489 (0%) | 4/490 (0.8%) | ||
Aortic Valve Incompetence | 0/489 (0%) | 1/490 (0.2%) | ||
Aortic Valve Stenosis | 0/489 (0%) | 1/490 (0.2%) | ||
Atrial Fibrillation | 6/489 (1.2%) | 3/490 (0.6%) | ||
Atrioventricular Block Complete | 0/489 (0%) | 1/490 (0.2%) | ||
Bradycardia | 0/489 (0%) | 2/490 (0.4%) | ||
Cardiac Failure | 3/489 (0.6%) | 2/490 (0.4%) | ||
Cardiac Failure Chronic | 1/489 (0.2%) | 0/490 (0%) | ||
Cardiac Failure Congestive | 4/489 (0.8%) | 4/490 (0.8%) | ||
Coronary Artery Disease | 2/489 (0.4%) | 1/490 (0.2%) | ||
Coronary Artery Stenosis | 1/489 (0.2%) | 0/490 (0%) | ||
Left Ventricular Dysfunction | 0/489 (0%) | 1/490 (0.2%) | ||
Myocardial Infarction | 1/489 (0.2%) | 6/490 (1.2%) | ||
Palpitations | 0/489 (0%) | 1/490 (0.2%) | ||
Sinus Node Dysfunction | 1/489 (0.2%) | 0/490 (0%) | ||
Stress Cardiomyopathy | 0/489 (0%) | 1/490 (0.2%) | ||
Supraventricular Tachycardia | 0/489 (0%) | 1/490 (0.2%) | ||
Ventricular Tachycardia | 0/489 (0%) | 2/490 (0.4%) | ||
Endocrine disorders | ||||
Inappropriate Antidiuretic Hormone Secretion | 1/489 (0.2%) | 0/490 (0%) | ||
Eye disorders | ||||
Cataract | 1/489 (0.2%) | 2/490 (0.4%) | ||
Diplopia | 1/489 (0.2%) | 0/490 (0%) | ||
Visual Impairment | 0/489 (0%) | 1/490 (0.2%) | ||
Gastrointestinal disorders | ||||
Anal Haemorrhage | 1/489 (0.2%) | 0/490 (0%) | ||
Constipation | 2/489 (0.4%) | 0/490 (0%) | ||
Diarrhoea | 1/489 (0.2%) | 2/490 (0.4%) | ||
Diverticulum | 1/489 (0.2%) | 0/490 (0%) | ||
Diverticulum Intestinal Haemorrhagic | 2/489 (0.4%) | 0/490 (0%) | ||
Duodenal Ulcer Perforation | 1/489 (0.2%) | 0/490 (0%) | ||
Enteritis | 1/489 (0.2%) | 0/490 (0%) | ||
Food Poisoning | 1/489 (0.2%) | 0/490 (0%) | ||
Gastric Haemorrhage | 1/489 (0.2%) | 0/490 (0%) | ||
Gastritis | 0/489 (0%) | 1/490 (0.2%) | ||
Gastrointestinal Haemorrhage | 3/489 (0.6%) | 2/490 (0.4%) | ||
Haematochezia | 1/489 (0.2%) | 0/490 (0%) | ||
Inguinal Hernia | 0/489 (0%) | 1/490 (0.2%) | ||
Intestinal Obstruction | 2/489 (0.4%) | 3/490 (0.6%) | ||
Large Intestine Polyp | 1/489 (0.2%) | 0/490 (0%) | ||
Lumbar Hernia | 0/489 (0%) | 1/490 (0.2%) | ||
Melaena | 1/489 (0.2%) | 0/490 (0%) | ||
Nausea | 2/489 (0.4%) | 0/490 (0%) | ||
Pancreatitis | 0/489 (0%) | 1/490 (0.2%) | ||
Peptic Ulcer Perforation | 1/489 (0.2%) | 0/490 (0%) | ||
Periodontal Disease | 1/489 (0.2%) | 0/490 (0%) | ||
Proctitis | 0/489 (0%) | 1/490 (0.2%) | ||
Rectal Haemorrhage | 5/489 (1%) | 0/490 (0%) | ||
Small Intestinal Obstruction | 0/489 (0%) | 1/490 (0.2%) | ||
Vomiting | 1/489 (0.2%) | 1/490 (0.2%) | ||
General disorders | ||||
Asthenia | 2/489 (0.4%) | 4/490 (0.8%) | ||
Fatigue | 0/489 (0%) | 1/490 (0.2%) | ||
Gait Inability | 0/489 (0%) | 1/490 (0.2%) | ||
General Physical Health Deterioration | 3/489 (0.6%) | 0/490 (0%) | ||
Generalised Oedema | 1/489 (0.2%) | 0/490 (0%) | ||
Granuloma | 0/489 (0%) | 1/490 (0.2%) | ||
Multiple Organ Dysfunction Syndrome | 3/489 (0.6%) | 0/490 (0%) | ||
Non-Cardiac Chest Pain | 1/489 (0.2%) | 5/490 (1%) | ||
Oedema Peripheral | 2/489 (0.4%) | 0/490 (0%) | ||
Pyrexia | 4/489 (0.8%) | 2/490 (0.4%) | ||
Systemic Inflammatory Response Syndrome | 1/489 (0.2%) | 0/490 (0%) | ||
Hepatobiliary disorders | ||||
Bile Duct Stone | 0/489 (0%) | 2/490 (0.4%) | ||
Cholangitis | 2/489 (0.4%) | 0/490 (0%) | ||
Cholecystitis | 0/489 (0%) | 1/490 (0.2%) | ||
Cholelithiasis | 1/489 (0.2%) | 0/490 (0%) | ||
Cholestasis | 1/489 (0.2%) | 0/490 (0%) | ||
Hepatic Function Abnormal | 1/489 (0.2%) | 0/490 (0%) | ||
Immune system disorders | ||||
Anaphylactic Reaction | 0/489 (0%) | 1/490 (0.2%) | ||
Contrast Media Allergy | 0/489 (0%) | 1/490 (0.2%) | ||
Infections and infestations | ||||
Appendicitis | 1/489 (0.2%) | 0/490 (0%) | ||
Appendicitis Perforated | 1/489 (0.2%) | 0/490 (0%) | ||
Bacteraemia | 1/489 (0.2%) | 1/490 (0.2%) | ||
Bronchitis | 1/489 (0.2%) | 2/490 (0.4%) | ||
Catheter Site Infection | 1/489 (0.2%) | 0/490 (0%) | ||
Cellulitis | 1/489 (0.2%) | 1/490 (0.2%) | ||
Clostridium Difficile Colitis | 1/489 (0.2%) | 0/490 (0%) | ||
Diverticulitis | 2/489 (0.4%) | 1/490 (0.2%) | ||
Erysipelas | 0/489 (0%) | 1/490 (0.2%) | ||
Gangrene | 1/489 (0.2%) | 0/490 (0%) | ||
Gastroenteritis | 2/489 (0.4%) | 2/490 (0.4%) | ||
Gastroenteritis Viral | 0/489 (0%) | 1/490 (0.2%) | ||
Gastrointestinal Infection | 1/489 (0.2%) | 0/490 (0%) | ||
Herpes Zoster | 0/489 (0%) | 1/490 (0.2%) | ||
Infection | 1/489 (0.2%) | 0/490 (0%) | ||
Influenza | 2/489 (0.4%) | 0/490 (0%) | ||
Legionella Infection | 0/489 (0%) | 1/490 (0.2%) | ||
Liver Abscess | 1/489 (0.2%) | 0/490 (0%) | ||
Localised Infection | 0/489 (0%) | 1/490 (0.2%) | ||
Lower Respiratory Tract Infection | 1/489 (0.2%) | 2/490 (0.4%) | ||
Osteomyelitis | 1/489 (0.2%) | 2/490 (0.4%) | ||
Pharyngitis | 0/489 (0%) | 1/490 (0.2%) | ||
Pneumonia | 10/489 (2%) | 18/490 (3.7%) | ||
Pneumonia Klebsiella | 0/489 (0%) | 1/490 (0.2%) | ||
Pneumonia Legionella | 0/489 (0%) | 1/490 (0.2%) | ||
Post Procedural Infection | 1/489 (0.2%) | 0/490 (0%) | ||
Prostate Infection | 0/489 (0%) | 1/490 (0.2%) | ||
Pseudomembranous Colitis | 1/489 (0.2%) | 0/490 (0%) | ||
Pulmonary Mycosis | 1/489 (0.2%) | 0/490 (0%) | ||
Pulmonary Tuberculosis | 1/489 (0.2%) | 0/490 (0%) | ||
Pyelonephritis | 1/489 (0.2%) | 4/490 (0.8%) | ||
Renal Abscess | 1/489 (0.2%) | 0/490 (0%) | ||
Respiratory Tract Infection | 1/489 (0.2%) | 1/490 (0.2%) | ||
Sepsis | 7/489 (1.4%) | 5/490 (1%) | ||
Septic Shock | 2/489 (0.4%) | 1/490 (0.2%) | ||
Sinusitis | 0/489 (0%) | 1/490 (0.2%) | ||
Staphylococcal Infection | 0/489 (0%) | 1/490 (0.2%) | ||
Tracheobronchitis | 0/489 (0%) | 1/490 (0.2%) | ||
Upper Respiratory Tract Infection | 2/489 (0.4%) | 0/490 (0%) | ||
Urinary Tract Infection | 7/489 (1.4%) | 12/490 (2.4%) | ||
Urosepsis | 2/489 (0.4%) | 2/490 (0.4%) | ||
Injury, poisoning and procedural complications | ||||
Alcohol Poisoning | 0/489 (0%) | 1/490 (0.2%) | ||
Ankle Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Cervical Vertebral Fracture | 1/489 (0.2%) | 0/490 (0%) | ||
Clavicle Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Fall | 1/489 (0.2%) | 8/490 (1.6%) | ||
Femoral Neck Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Femur Fracture | 1/489 (0.2%) | 3/490 (0.6%) | ||
Foot Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Hand Fracture | 0/489 (0%) | 2/490 (0.4%) | ||
Hip Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Humerus Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Limb Traumatic Amputation | 0/489 (0%) | 1/490 (0.2%) | ||
Lower Limb Fracture | 1/489 (0.2%) | 0/490 (0%) | ||
Lumbar Vertebral Fracture | 2/489 (0.4%) | 0/490 (0%) | ||
Multiple Fractures | 0/489 (0%) | 1/490 (0.2%) | ||
Muscle Strain | 1/489 (0.2%) | 0/490 (0%) | ||
Pelvic Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Radius Fracture | 1/489 (0.2%) | 0/490 (0%) | ||
Rib Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Spinal Compression Fracture | 0/489 (0%) | 2/490 (0.4%) | ||
Spinal Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Subdural Haematoma | 0/489 (0%) | 2/490 (0.4%) | ||
Toxicity to Various Agents | 0/489 (0%) | 1/490 (0.2%) | ||
Traumatic Fracture | 0/489 (0%) | 1/490 (0.2%) | ||
Upper Limb Fracture | 1/489 (0.2%) | 0/490 (0%) | ||
Investigations | ||||
Alanine Aminotransferase Increased | 1/489 (0.2%) | 0/490 (0%) | ||
Blood Creatinine Increased | 0/489 (0%) | 2/490 (0.4%) | ||
Oxygen Saturation Decreased | 0/489 (0%) | 1/490 (0.2%) | ||
Metabolism and nutrition disorders | ||||
Decreased Appetite | 2/489 (0.4%) | 0/490 (0%) | ||
Dehydration | 2/489 (0.4%) | 2/490 (0.4%) | ||
Diabetes Mellitus | 0/489 (0%) | 1/490 (0.2%) | ||
Diabetes Mellitus Inadequate Control | 1/489 (0.2%) | 0/490 (0%) | ||
Failure to Thrive | 0/489 (0%) | 1/490 (0.2%) | ||
Hyperglycaemia | 3/489 (0.6%) | 1/490 (0.2%) | ||
Hyperkalaemia | 1/489 (0.2%) | 0/490 (0%) | ||
Hypokalaemia | 2/489 (0.4%) | 2/490 (0.4%) | ||
Hyponatraemia | 1/489 (0.2%) | 0/490 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 0/489 (0%) | 4/490 (0.8%) | ||
Back Pain | 8/489 (1.6%) | 4/490 (0.8%) | ||
Bone Pain | 2/489 (0.4%) | 3/490 (0.6%) | ||
Flank Pain | 0/489 (0%) | 1/490 (0.2%) | ||
Muscular Weakness | 3/489 (0.6%) | 0/490 (0%) | ||
Osteoarthritis | 0/489 (0%) | 2/490 (0.4%) | ||
Osteoporosis | 0/489 (0%) | 1/490 (0.2%) | ||
Pain in Extremity | 0/489 (0%) | 3/490 (0.6%) | ||
Pathological Fracture | 3/489 (0.6%) | 2/490 (0.4%) | ||
Rheumatoid Arthritis | 0/489 (0%) | 1/490 (0.2%) | ||
Spinal Osteoarthritis | 0/489 (0%) | 1/490 (0.2%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Astrocytoma | 1/489 (0.2%) | 0/490 (0%) | ||
B-Cell Lymphoma | 1/489 (0.2%) | 0/490 (0%) | ||
Basal Cell Carcinoma | 1/489 (0.2%) | 1/490 (0.2%) | ||
Bladder Transitional Cell Carcinoma | 1/489 (0.2%) | 0/490 (0%) | ||
Cancer Pain | 1/489 (0.2%) | 0/490 (0%) | ||
Colon Cancer | 1/489 (0.2%) | 0/490 (0%) | ||
Colorectal Adenocarcinoma | 0/489 (0%) | 1/490 (0.2%) | ||
Gallbladder Cancer | 0/489 (0%) | 1/490 (0.2%) | ||
Gastric Neoplasm | 1/489 (0.2%) | 0/490 (0%) | ||
Hepatic Cancer | 0/489 (0%) | 1/490 (0.2%) | ||
Intestinal Metastasis | 0/489 (0%) | 1/490 (0.2%) | ||
Intraductal Papillary Mucinous Neoplasm | 0/489 (0%) | 1/490 (0.2%) | ||
Lung Adenocarcinoma | 1/489 (0.2%) | 0/490 (0%) | ||
Malignant Melanoma | 0/489 (0%) | 1/490 (0.2%) | ||
Metastases to Bone | 0/489 (0%) | 1/490 (0.2%) | ||
Metastatic Malignant Melanoma | 0/489 (0%) | 1/490 (0.2%) | ||
Oesophageal Adenocarcinoma | 0/489 (0%) | 1/490 (0.2%) | ||
Oesophageal Neoplasm | 0/489 (0%) | 1/490 (0.2%) | ||
Pancreatic Carcinoma | 0/489 (0%) | 1/490 (0.2%) | ||
Prostate Cancer Metastatic | 1/489 (0.2%) | 0/490 (0%) | ||
Small Cell Carcinoma | 0/489 (0%) | 1/490 (0.2%) | ||
Squamous Cell Carcinoma | 0/489 (0%) | 1/490 (0.2%) | ||
Thyroid Cancer | 0/489 (0%) | 1/490 (0.2%) | ||
Transitional Cell Carcinoma | 0/489 (0%) | 1/490 (0.2%) | ||
Nervous system disorders | ||||
Altered State of Consciousness | 0/489 (0%) | 1/490 (0.2%) | ||
Carotid Artery Stenosis | 2/489 (0.4%) | 0/490 (0%) | ||
Cerebral Haemorrhage | 0/489 (0%) | 1/490 (0.2%) | ||
Cerebrovascular Accident | 4/489 (0.8%) | 2/490 (0.4%) | ||
Cognitive Disorder | 0/489 (0%) | 1/490 (0.2%) | ||
Dementia | 1/489 (0.2%) | 1/490 (0.2%) | ||
Dizziness | 1/489 (0.2%) | 1/490 (0.2%) | ||
Embolic Cerebral Infarction | 1/489 (0.2%) | 0/490 (0%) | ||
Encephalopathy | 1/489 (0.2%) | 0/490 (0%) | ||
Haemorrhagic Stroke | 0/489 (0%) | 1/490 (0.2%) | ||
Headache | 0/489 (0%) | 1/490 (0.2%) | ||
Ischaemic Stroke | 2/489 (0.4%) | 1/490 (0.2%) | ||
Loss of Consciousness | 1/489 (0.2%) | 0/490 (0%) | ||
Nervous System Disorder | 1/489 (0.2%) | 0/490 (0%) | ||
Neuralgia | 0/489 (0%) | 1/490 (0.2%) | ||
Parkinson's Disease | 1/489 (0.2%) | 0/490 (0%) | ||
Peripheral Motor Neuropathy | 1/489 (0.2%) | 0/490 (0%) | ||
Presyncope | 3/489 (0.6%) | 1/490 (0.2%) | ||
Sciatica | 0/489 (0%) | 1/490 (0.2%) | ||
Seizure | 0/489 (0%) | 2/490 (0.4%) | ||
Spinal Cord Compression | 3/489 (0.6%) | 5/490 (1%) | ||
Subarachnoid Haemorrhage | 1/489 (0.2%) | 0/490 (0%) | ||
Syncope | 5/489 (1%) | 6/490 (1.2%) | ||
Transient Ischaemic Attack | 1/489 (0.2%) | 3/490 (0.6%) | ||
Product Issues | ||||
Device Occlusion | 0/489 (0%) | 2/490 (0.4%) | ||
Psychiatric disorders | ||||
Anxiety | 1/489 (0.2%) | 1/490 (0.2%) | ||
Confusional State | 0/489 (0%) | 1/490 (0.2%) | ||
Delirium | 0/489 (0%) | 1/490 (0.2%) | ||
Renal and urinary disorders | ||||
Acute Kidney Injury | 7/489 (1.4%) | 6/490 (1.2%) | ||
Bladder Obstruction | 0/489 (0%) | 1/490 (0.2%) | ||
Calculus Bladder | 1/489 (0.2%) | 1/490 (0.2%) | ||
Haematuria | 13/489 (2.7%) | 6/490 (1.2%) | ||
Hydronephrosis | 0/489 (0%) | 4/490 (0.8%) | ||
Nephrolithiasis | 2/489 (0.4%) | 1/490 (0.2%) | ||
Oliguria | 1/489 (0.2%) | 0/490 (0%) | ||
Renal Failure | 0/489 (0%) | 1/490 (0.2%) | ||
Renal Impairment | 0/489 (0%) | 1/490 (0.2%) | ||
Ureteric Obstruction | 0/489 (0%) | 1/490 (0.2%) | ||
Urethral Stenosis | 1/489 (0.2%) | 1/490 (0.2%) | ||
Urinary Incontinence | 1/489 (0.2%) | 3/490 (0.6%) | ||
Urinary Retention | 3/489 (0.6%) | 3/490 (0.6%) | ||
Urinary Tract Obstruction | 1/489 (0.2%) | 4/490 (0.8%) | ||
Reproductive system and breast disorders | ||||
Testicular Pain | 0/489 (0%) | 1/490 (0.2%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Acute Respiratory Failure | 1/489 (0.2%) | 1/490 (0.2%) | ||
Chronic Obstructive Pulmonary Disease | 2/489 (0.4%) | 1/490 (0.2%) | ||
Cough | 1/489 (0.2%) | 0/490 (0%) | ||
Dyspnoea | 1/489 (0.2%) | 0/490 (0%) | ||
Epistaxis | 1/489 (0.2%) | 1/490 (0.2%) | ||
Pneumothorax | 1/489 (0.2%) | 1/490 (0.2%) | ||
Pulmonary Congestion | 1/489 (0.2%) | 0/490 (0%) | ||
Pulmonary Embolism | 6/489 (1.2%) | 1/490 (0.2%) | ||
Pulmonary Fibrosis | 1/489 (0.2%) | 0/490 (0%) | ||
Pulmonary Oedema | 1/489 (0.2%) | 0/490 (0%) | ||
Respiratory Failure | 3/489 (0.6%) | 0/490 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Rash | 0/489 (0%) | 2/490 (0.4%) | ||
Rash Pruritic | 0/489 (0%) | 1/490 (0.2%) | ||
Skin Ulcer | 1/489 (0.2%) | 0/490 (0%) | ||
Subcutaneous Emphysema | 1/489 (0.2%) | 0/490 (0%) | ||
Surgical and medical procedures | ||||
Coronary Angioplasty | 1/489 (0.2%) | 0/490 (0%) | ||
Vascular disorders | ||||
Aortic Aneurysm | 2/489 (0.4%) | 2/490 (0.4%) | ||
Aortic Dissection | 0/489 (0%) | 1/490 (0.2%) | ||
Aortic Stenosis | 1/489 (0.2%) | 0/490 (0%) | ||
Deep Vein Thrombosis | 4/489 (0.8%) | 1/490 (0.2%) | ||
Embolism | 2/489 (0.4%) | 0/490 (0%) | ||
Haemodynamic Instability | 1/489 (0.2%) | 0/490 (0%) | ||
Hypertension | 3/489 (0.6%) | 1/490 (0.2%) | ||
Hypertensive Urgency | 0/489 (0%) | 1/490 (0.2%) | ||
Hypotension | 1/489 (0.2%) | 1/490 (0.2%) | ||
Pelvic Venous Thrombosis | 1/489 (0.2%) | 0/490 (0%) | ||
Peripheral Arterial Occlusive Disease | 1/489 (0.2%) | 0/490 (0%) | ||
Peripheral Ischaemia | 0/489 (0%) | 1/490 (0.2%) | ||
Thrombosis | 0/489 (0%) | 1/490 (0.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
Placebo+ Abiraterone Acetate - Prednisolone | Apalutamide + Abiraterone Acetate - Prednisolone | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 459/489 (93.9%) | 472/490 (96.3%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 77/489 (15.7%) | 70/490 (14.3%) | ||
Endocrine disorders | ||||
Hypothyroidism | 8/489 (1.6%) | 27/490 (5.5%) | ||
Gastrointestinal disorders | ||||
Abdominal Pain | 25/489 (5.1%) | 24/490 (4.9%) | ||
Constipation | 94/489 (19.2%) | 96/490 (19.6%) | ||
Diarrhoea | 73/489 (14.9%) | 91/490 (18.6%) | ||
Dyspepsia | 21/489 (4.3%) | 28/490 (5.7%) | ||
Nausea | 76/489 (15.5%) | 84/490 (17.1%) | ||
Vomiting | 35/489 (7.2%) | 39/490 (8%) | ||
General disorders | ||||
Asthenia | 63/489 (12.9%) | 65/490 (13.3%) | ||
Fatigue | 134/489 (27.4%) | 164/490 (33.5%) | ||
Oedema Peripheral | 72/489 (14.7%) | 77/490 (15.7%) | ||
Pyrexia | 36/489 (7.4%) | 36/490 (7.3%) | ||
Infections and infestations | ||||
Influenza | 28/489 (5.7%) | 20/490 (4.1%) | ||
Nasopharyngitis | 57/489 (11.7%) | 52/490 (10.6%) | ||
Upper Respiratory Tract Infection | 40/489 (8.2%) | 42/490 (8.6%) | ||
Urinary Tract Infection | 49/489 (10%) | 37/490 (7.6%) | ||
Injury, poisoning and procedural complications | ||||
Contusion | 49/489 (10%) | 34/490 (6.9%) | ||
Fall | 92/489 (18.8%) | 106/490 (21.6%) | ||
Rib Fracture | 23/489 (4.7%) | 25/490 (5.1%) | ||
Investigations | ||||
Alanine Aminotransferase Increased | 57/489 (11.7%) | 20/490 (4.1%) | ||
Aspartate Aminotransferase Increased | 53/489 (10.8%) | 21/490 (4.3%) | ||
Blood Alkaline Phosphatase Increased | 34/489 (7%) | 19/490 (3.9%) | ||
Blood Pressure Increased | 17/489 (3.5%) | 26/490 (5.3%) | ||
Weight Decreased | 84/489 (17.2%) | 136/490 (27.8%) | ||
Weight Increased | 28/489 (5.7%) | 12/490 (2.4%) | ||
Metabolism and nutrition disorders | ||||
Decreased Appetite | 60/489 (12.3%) | 72/490 (14.7%) | ||
Hypercholesterolaemia | 18/489 (3.7%) | 28/490 (5.7%) | ||
Hyperglycaemia | 37/489 (7.6%) | 29/490 (5.9%) | ||
Hypokalaemia | 73/489 (14.9%) | 79/490 (16.1%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 121/489 (24.7%) | 127/490 (25.9%) | ||
Back Pain | 133/489 (27.2%) | 154/490 (31.4%) | ||
Bone Pain | 48/489 (9.8%) | 34/490 (6.9%) | ||
Muscle Spasms | 45/489 (9.2%) | 30/490 (6.1%) | ||
Musculoskeletal Chest Pain | 50/489 (10.2%) | 48/490 (9.8%) | ||
Musculoskeletal Pain | 46/489 (9.4%) | 50/490 (10.2%) | ||
Myalgia | 28/489 (5.7%) | 27/490 (5.5%) | ||
Neck Pain | 13/489 (2.7%) | 26/490 (5.3%) | ||
Pain in Extremity | 57/489 (11.7%) | 79/490 (16.1%) | ||
Nervous system disorders | ||||
Dizziness | 46/489 (9.4%) | 61/490 (12.4%) | ||
Dysgeusia | 12/489 (2.5%) | 33/490 (6.7%) | ||
Headache | 63/489 (12.9%) | 79/490 (16.1%) | ||
Psychiatric disorders | ||||
Anxiety | 16/489 (3.3%) | 28/490 (5.7%) | ||
Insomnia | 30/489 (6.1%) | 46/490 (9.4%) | ||
Renal and urinary disorders | ||||
Haematuria | 40/489 (8.2%) | 42/490 (8.6%) | ||
Pollakiuria | 31/489 (6.3%) | 21/490 (4.3%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 66/489 (13.5%) | 53/490 (10.8%) | ||
Dyspnoea | 43/489 (8.8%) | 41/490 (8.4%) | ||
Skin and subcutaneous tissue disorders | ||||
Rash | 24/489 (4.9%) | 44/490 (9%) | ||
Vascular disorders | ||||
Hot Flush | 56/489 (11.5%) | 74/490 (15.1%) | ||
Hypertension | 122/489 (24.9%) | 144/490 (29.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
Results Point of Contact
Name/Title | Executive Medical Director |
---|---|
Organization | Aragon Pharmaceuticals, Inc. |
Phone | 844-434-4210 |
ClinicalTrialDisclosure@its.jnj.com |
- CR105505
- 56021927PCR3001
- 2014-001718-25