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A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)

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: NCT01946204
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Results First Posted : June 19, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Prostatic Neoplasms
Interventions Drug: Apalutamide
Drug: Placebo
Enrollment 1207
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death. Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Period Title: Overall Study
Started 401 806
Treated 398 803
Completed 0 0
Not Completed 401 806
Reason Not Completed
Death             38             59
Withdrawal by Subject             37             50
Lost to Follow-up             3             7
Ongoing             316             687
Other             7             3
Arm/Group Title Placebo Apalutamide Total
Hide Arm/Group Description Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death. Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death. Total of all reporting groups
Overall Number of Baseline Participants 401 806 1207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 401 participants 806 participants 1207 participants
74.1  (7.92) 73.7  (8.07) 73.9  (8.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 806 participants 1207 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
401
 100.0%
806
 100.0%
1207
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 806 participants 1207 participants
Hispanic or Latino
5
   1.2%
11
   1.4%
16
   1.3%
Not Hispanic or Latino
338
  84.3%
659
  81.8%
997
  82.6%
Unknown or Not Reported
58
  14.5%
136
  16.9%
194
  16.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 806 participants 1207 participants
American Indian or Alaska Native
0
   0.0%
4
   0.5%
4
   0.3%
Asian
47
  11.7%
93
  11.5%
140
  11.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
   5.0%
48
   6.0%
68
   5.6%
White
276
  68.8%
524
  65.0%
800
  66.3%
More than one race
0
   0.0%
1
   0.1%
1
   0.1%
Unknown or Not Reported
58
  14.5%
136
  16.9%
194
  16.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 806 participants 1207 participants
Australia
11
   2.7%
30
   3.7%
41
   3.4%
Austria
2
   0.5%
4
   0.5%
6
   0.5%
Belgium
3
   0.7%
4
   0.5%
7
   0.6%
Canada
21
   5.2%
61
   7.6%
82
   6.8%
Czech Republic
14
   3.5%
20
   2.5%
34
   2.8%
Denmark
7
   1.7%
14
   1.7%
21
   1.7%
Finland
5
   1.2%
7
   0.9%
12
   1.0%
France
21
   5.2%
39
   4.8%
60
   5.0%
Germany
20
   5.0%
31
   3.8%
51
   4.2%
Hungary
1
   0.2%
4
   0.5%
5
   0.4%
Israel
7
   1.7%
7
   0.9%
14
   1.2%
Italy
12
   3.0%
24
   3.0%
36
   3.0%
Japan
21
   5.2%
34
   4.2%
55
   4.6%
Netherlands
11
   2.7%
8
   1.0%
19
   1.6%
New Zealand
2
   0.5%
6
   0.7%
8
   0.7%
Norway
3
   0.7%
4
   0.5%
7
   0.6%
Poland
6
   1.5%
28
   3.5%
34
   2.8%
Romania
5
   1.2%
7
   0.9%
12
   1.0%
Russia
11
   2.7%
24
   3.0%
35
   2.9%
Slovakia
6
   1.5%
11
   1.4%
17
   1.4%
South Africa
17
   4.2%
35
   4.3%
52
   4.3%
Spain
36
   9.0%
95
  11.8%
131
  10.9%
Sweden
3
   0.7%
10
   1.2%
13
   1.1%
Taiwan, Province Of China
5
   1.2%
14
   1.7%
19
   1.6%
United Kingdom
38
   9.5%
61
   7.6%
99
   8.2%
United States
113
  28.2%
224
  27.8%
337
  27.9%
1.Primary Outcome
Title Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
Hide Description MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography [CT] or magnetic resonance imaging [MRI] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Time Frame Up to approximately 43 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description:
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Overall Number of Participants Analyzed 401 806
Median (95% Confidence Interval)
Unit of Measure: Months
US Regulatory
16.20
(14.59 to 18.40)
40.51 [1] 
(NA to NA)
Ex-US Regulatory
15.70
(14.55 to 18.40)
40.51
(29.70 to 40.51)
[1]
NA signifies: lower and upper limit of Confidence Interval(CI) was not estimable as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of Statistical Analysis System[SAS] Proc Lifetest).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for MFS by BICR (US Regulatory)
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 0.280
Confidence Interval (2-Sided) 95%
0.227 to 0.346
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for MFS by BICR (Ex-US Regulatory)
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 0.297
Confidence Interval (2-Sided) 95%
0.244 to 0.362
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Metastasis (TTM)
Hide Description Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Time Frame Up to approximately 43 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description:
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Overall Number of Participants Analyzed 401 806
Median (95% Confidence Interval)
Unit of Measure: Months
US Regulatory
16.59
(14.59 to 18.46)
40.51 [1] 
(NA to NA)
EX-US Regulatory
15.70
(14.55 to 18.40)
40.51
(31.15 to 40.51)
[1]
NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for TTM by BICR (US Regulatory)
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 0.271
Confidence Interval (2-Sided) 95%
0.219 to 0.335
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for TTM by BICR (Ex-US Regulatory)
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 0.279
Confidence Interval (2-Sided) 95%
0.227 to 0.342
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
Time Frame Up to approximately 43 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description:
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Overall Number of Participants Analyzed 401 806
Median (95% Confidence Interval)
Unit of Measure: Months
US Regulatory
14.72
(14.49 to 18.37)
40.51 [1] 
(NA to NA)
EX-US Regulatory
14.65
(11.27 to 17.97)
40.51
(29.40 to 40.51)
[1]
NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for PFS by BICR (US Regulatory)
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 0.291
Confidence Interval (2-Sided) 95%
0.238 to 0.356
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for PFS by BICR (EX-US Regulatory)
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 0.300
Confidence Interval (2-Sided) 95%
0.247 to 0.364
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Symptomatic Progression
Hide Description Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
Time Frame Up to approximately 43 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description:
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Overall Number of Participants Analyzed 401 806
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(36.83 to NA)
NA [2] 
(NA to NA)
[1]
NA signifies: median and upper limit of CI were NA. Median was NA as KM curve did not drop to 0.5 or below. Upper limit was NA as upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
[2]
The median was not estimable(NA) as Kaplan–Meier(KM) curve did not drop to 0.5 or below. The lower or upper limit was NA as lower or upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apalutamide
Comments Statistical Analysis for Time to Symptomatic Progression
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 0.447
Confidence Interval (2-Sided) 95%
0.315 to 0.634
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization to the date of death due to any cause.
Time Frame Up to approximately 43 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description:
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Overall Number of Participants Analyzed 401 806
Median (95% Confidence Interval)
Unit of Measure: Months
39.03 [1] 
(39.03 to NA)
NA [2] 
(NA to NA)
[1]
Here NA signifies that the upper limit of Confidence Interval (CI) was not estimable as upper limit of CI for the survivor function was above 0.5 using log(-log) transformation (the default of SAS Proc Lifetest).
[2]
The median was not estimable(NA) as Kaplan–Meier(KM) curve did not drop to 0.5 or below. The lower or upper limit was NA as lower or upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
6.Secondary Outcome
Title Time to Initiation of Cytotoxic Chemotherapy
Hide Description Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Time Frame Up to approximately 43 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description:
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Overall Number of Participants Analyzed 401 806
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median was not estimable (NA) as KM curve did not drop to 0.5 or below. The lower or upper limit was NA as lower or upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
Time Frame Up to approximately 43 months
Adverse Event Reporting Description Safety population included all participants who received at least one dose of study drug.
 
Arm/Group Title Placebo Apalutamide
Hide Arm/Group Description Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death. Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
All-Cause Mortality
Placebo Apalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   1/398 (0.25%)   10/803 (1.25%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Apalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   92/398 (23.12%)   199/803 (24.78%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/398 (0.50%)  2/803 (0.25%) 
Haemolytic Uraemic Syndrome * 1  1/398 (0.25%)  0/803 (0.00%) 
Neutropenia * 1  0/398 (0.00%)  1/803 (0.12%) 
Pancytopenia * 1  0/398 (0.00%)  1/803 (0.12%) 
Thrombocytopenia * 1  1/398 (0.25%)  2/803 (0.25%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  1/398 (0.25%)  1/803 (0.12%) 
Acute Myocardial Infarction * 1  1/398 (0.25%)  1/803 (0.12%) 
Angina Pectoris * 1  1/398 (0.25%)  1/803 (0.12%) 
Angina Unstable * 1  0/398 (0.00%)  1/803 (0.12%) 
Aortic Valve Incompetence * 1  0/398 (0.00%)  1/803 (0.12%) 
Atrial Fibrillation * 1  2/398 (0.50%)  7/803 (0.87%) 
Atrial Flutter * 1  0/398 (0.00%)  1/803 (0.12%) 
Bradycardia * 1  0/398 (0.00%)  1/803 (0.12%) 
Cardiac Failure * 1  0/398 (0.00%)  3/803 (0.37%) 
Cardiac Failure Acute * 1  1/398 (0.25%)  0/803 (0.00%) 
Cardiac Failure Congestive * 1  1/398 (0.25%)  4/803 (0.50%) 
Cardiomyopathy * 1  0/398 (0.00%)  2/803 (0.25%) 
Coronary Artery Disease * 1  1/398 (0.25%)  3/803 (0.37%) 
Coronary Artery Occlusion * 1  0/398 (0.00%)  1/803 (0.12%) 
Myocardial Infarction * 1  0/398 (0.00%)  3/803 (0.37%) 
Myocardial Ischaemia * 1  1/398 (0.25%)  1/803 (0.12%) 
Right Ventricular Dysfunction * 1  0/398 (0.00%)  1/803 (0.12%) 
Sinus Node Dysfunction * 1  0/398 (0.00%)  1/803 (0.12%) 
Stress Cardiomyopathy * 1  1/398 (0.25%)  0/803 (0.00%) 
Supraventricular Tachycardia * 1  0/398 (0.00%)  1/803 (0.12%) 
Ventricular Tachycardia * 1  0/398 (0.00%)  1/803 (0.12%) 
Congenital, familial and genetic disorders     
Hydrocele * 1  1/398 (0.25%)  0/803 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  2/398 (0.50%)  1/803 (0.12%) 
Endocrine disorders     
Hypothyroidism * 1  0/398 (0.00%)  1/803 (0.12%) 
Eye disorders     
Choroidal Haemorrhage * 1  1/398 (0.25%)  0/803 (0.00%) 
Open Angle Glaucoma * 1  0/398 (0.00%)  1/803 (0.12%) 
Retinal Detachment * 1  0/398 (0.00%)  1/803 (0.12%) 
Gastrointestinal disorders     
Abdominal Hernia * 1  0/398 (0.00%)  1/803 (0.12%) 
Abdominal Pain * 1  2/398 (0.50%)  2/803 (0.25%) 
Chronic Gastritis * 1  0/398 (0.00%)  1/803 (0.12%) 
Colitis * 1  1/398 (0.25%)  0/803 (0.00%) 
Diarrhoea * 1  1/398 (0.25%)  5/803 (0.62%) 
Enteritis * 1  0/398 (0.00%)  1/803 (0.12%) 
Erosive Duodenitis * 1  0/398 (0.00%)  1/803 (0.12%) 
Gastrointestinal Haemorrhage * 1  1/398 (0.25%)  2/803 (0.25%) 
Gastrooesophageal Reflux Disease * 1  1/398 (0.25%)  1/803 (0.12%) 
Gingival Bleeding * 1  0/398 (0.00%)  1/803 (0.12%) 
Ileus * 1  1/398 (0.25%)  1/803 (0.12%) 
Incarcerated Umbilical Hernia * 1  0/398 (0.00%)  1/803 (0.12%) 
Inguinal Hernia * 1  1/398 (0.25%)  0/803 (0.00%) 
Inguinal Hernia Strangulated * 1  0/398 (0.00%)  1/803 (0.12%) 
Intestinal Haemorrhage * 1  0/398 (0.00%)  1/803 (0.12%) 
Intestinal Mass * 1  1/398 (0.25%)  0/803 (0.00%) 
Large Intestine Polyp * 1  0/398 (0.00%)  1/803 (0.12%) 
Lower Gastrointestinal Haemorrhage * 1  1/398 (0.25%)  1/803 (0.12%) 
Melaena * 1  1/398 (0.25%)  1/803 (0.12%) 
Mouth Ulceration * 1  0/398 (0.00%)  1/803 (0.12%) 
Nausea * 1  0/398 (0.00%)  1/803 (0.12%) 
Oesophageal Achalasia * 1  0/398 (0.00%)  1/803 (0.12%) 
Pancreatitis * 1  1/398 (0.25%)  0/803 (0.00%) 
Pancreatitis Acute * 1  1/398 (0.25%)  0/803 (0.00%) 
Rectal Haemorrhage * 1  0/398 (0.00%)  2/803 (0.25%) 
Small Intestinal Haemorrhage * 1  1/398 (0.25%)  0/803 (0.00%) 
Small Intestinal Obstruction * 1  1/398 (0.25%)  2/803 (0.25%) 
Umbilical Hernia * 1  0/398 (0.00%)  1/803 (0.12%) 
Vomiting * 1  0/398 (0.00%)  2/803 (0.25%) 
General disorders     
Asthenia * 1  0/398 (0.00%)  1/803 (0.12%) 
Chest Pain * 1  0/398 (0.00%)  1/803 (0.12%) 
Dystrophic Calcification * 1  0/398 (0.00%)  1/803 (0.12%) 
Gait Disturbance * 1  1/398 (0.25%)  1/803 (0.12%) 
General Physical Health Deterioration * 1  0/398 (0.00%)  2/803 (0.25%) 
Hyperthermia * 1  0/398 (0.00%)  1/803 (0.12%) 
Multiple Organ Dysfunction Syndrome * 1  0/398 (0.00%)  1/803 (0.12%) 
Non-Cardiac Chest Pain * 1  1/398 (0.25%)  3/803 (0.37%) 
Oedema Peripheral * 1  0/398 (0.00%)  1/803 (0.12%) 
Pain * 1  0/398 (0.00%)  1/803 (0.12%) 
Pyrexia * 1  0/398 (0.00%)  5/803 (0.62%) 
Soft Tissue Inflammation * 1  0/398 (0.00%)  1/803 (0.12%) 
Hepatobiliary disorders     
Cholangitis Acute * 1  1/398 (0.25%)  0/803 (0.00%) 
Cholecystitis * 1  0/398 (0.00%)  3/803 (0.37%) 
Cholelithiasis * 1  1/398 (0.25%)  0/803 (0.00%) 
Hyperbilirubinaemia * 1  0/398 (0.00%)  1/803 (0.12%) 
Infections and infestations     
Anal Abscess * 1  0/398 (0.00%)  1/803 (0.12%) 
Appendiceal Abscess * 1  1/398 (0.25%)  0/803 (0.00%) 
Appendicitis * 1  0/398 (0.00%)  2/803 (0.25%) 
Bronchitis * 1  0/398 (0.00%)  1/803 (0.12%) 
Cellulitis * 1  1/398 (0.25%)  3/803 (0.37%) 
Cellulitis Streptococcal * 1  0/398 (0.00%)  1/803 (0.12%) 
Cellulitis of Male External Genital Organ * 1  0/398 (0.00%)  1/803 (0.12%) 
Clostridium Difficile Infection * 1  0/398 (0.00%)  2/803 (0.25%) 
Cystitis * 1  1/398 (0.25%)  1/803 (0.12%) 
Diverticulitis * 1  0/398 (0.00%)  1/803 (0.12%) 
Erysipelas * 1  0/398 (0.00%)  1/803 (0.12%) 
Gastroenteritis Clostridial * 1  0/398 (0.00%)  1/803 (0.12%) 
H1n1 Influenza * 1  0/398 (0.00%)  1/803 (0.12%) 
Influenza * 1  0/398 (0.00%)  1/803 (0.12%) 
Necrotising Fasciitis * 1  1/398 (0.25%)  0/803 (0.00%) 
Osteomyelitis * 1  0/398 (0.00%)  2/803 (0.25%) 
Pneumonia * 1  2/398 (0.50%)  9/803 (1.12%) 
Pneumonia Parainfluenzae Viral * 1  0/398 (0.00%)  1/803 (0.12%) 
Prostatic Abscess * 1  0/398 (0.00%)  1/803 (0.12%) 
Pulmonary Tuberculosis * 1  0/398 (0.00%)  1/803 (0.12%) 
Sepsis * 1  0/398 (0.00%)  7/803 (0.87%) 
Severe Fever with Thrombocytopenia Syndrome * 1  0/398 (0.00%)  1/803 (0.12%) 
Skin Infection * 1  0/398 (0.00%)  1/803 (0.12%) 
Staphylococcal Skin Infection * 1  0/398 (0.00%)  1/803 (0.12%) 
Urinary Tract Infection * 1  3/398 (0.75%)  10/803 (1.25%) 
Urinary Tract Infection Bacterial * 1  0/398 (0.00%)  1/803 (0.12%) 
Urosepsis * 1  0/398 (0.00%)  5/803 (0.62%) 
Injury, poisoning and procedural complications     
Acetabulum Fracture * 1  0/398 (0.00%)  2/803 (0.25%) 
Anastomotic Complication * 1  0/398 (0.00%)  1/803 (0.12%) 
Ankle Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Avulsion Fracture * 1  1/398 (0.25%)  0/803 (0.00%) 
Compression Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Craniocerebral Injury * 1  0/398 (0.00%)  1/803 (0.12%) 
Facial Bones Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Fall * 1  1/398 (0.25%)  6/803 (0.75%) 
Femoral Neck Fracture * 1  1/398 (0.25%)  0/803 (0.00%) 
Femur Fracture * 1  1/398 (0.25%)  3/803 (0.37%) 
Foot Fracture * 1  0/398 (0.00%)  2/803 (0.25%) 
Gastrointestinal Stoma Complication * 1  1/398 (0.25%)  0/803 (0.00%) 
Hip Fracture * 1  0/398 (0.00%)  2/803 (0.25%) 
Humerus Fracture * 1  0/398 (0.00%)  2/803 (0.25%) 
Joint Injury * 1  0/398 (0.00%)  1/803 (0.12%) 
Ligament Sprain * 1  0/398 (0.00%)  1/803 (0.12%) 
Lower Limb Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Lumbar Vertebral Fracture * 1  0/398 (0.00%)  3/803 (0.37%) 
Perirenal Haematoma * 1  0/398 (0.00%)  1/803 (0.12%) 
Pneumothorax Traumatic * 1  0/398 (0.00%)  1/803 (0.12%) 
Procedural Pain * 1  0/398 (0.00%)  1/803 (0.12%) 
Pubis Fracture * 1  0/398 (0.00%)  2/803 (0.25%) 
Radius Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Rib Fracture * 1  0/398 (0.00%)  2/803 (0.25%) 
Road Traffic Accident * 1  0/398 (0.00%)  1/803 (0.12%) 
Seroma * 1  0/398 (0.00%)  1/803 (0.12%) 
Spinal Fracture * 1  0/398 (0.00%)  3/803 (0.37%) 
Subdural Haematoma * 1  0/398 (0.00%)  1/803 (0.12%) 
Thoracic Vertebral Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Toxicity to Various Agents * 1  0/398 (0.00%)  1/803 (0.12%) 
Upper Limb Fracture * 1  0/398 (0.00%)  1/803 (0.12%) 
Investigations     
Alanine Aminotransferase Increased * 1  0/398 (0.00%)  2/803 (0.25%) 
Aspartate Aminotransferase Increased * 1  0/398 (0.00%)  2/803 (0.25%) 
Blood Bilirubin Increased * 1  0/398 (0.00%)  1/803 (0.12%) 
Blood Urine Present * 1  1/398 (0.25%)  0/803 (0.00%) 
Eastern Cooperative Oncology Group Performance Status Worsened * 1  0/398 (0.00%)  1/803 (0.12%) 
Weight Decreased * 1  0/398 (0.00%)  2/803 (0.25%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  0/398 (0.00%)  1/803 (0.12%) 
Dehydration * 1  0/398 (0.00%)  3/803 (0.37%) 
Hyperglycaemia * 1  0/398 (0.00%)  3/803 (0.37%) 
Hyponatraemia * 1  1/398 (0.25%)  1/803 (0.12%) 
Metabolic Alkalosis * 1  0/398 (0.00%)  1/803 (0.12%) 
Musculoskeletal and connective tissue disorders     
Arthritis * 1  0/398 (0.00%)  1/803 (0.12%) 
Back Pain * 1  1/398 (0.25%)  2/803 (0.25%) 
Gouty Arthritis * 1  0/398 (0.00%)  1/803 (0.12%) 
Joint Swelling * 1  0/398 (0.00%)  1/803 (0.12%) 
Lumbar Spinal Stenosis * 1  0/398 (0.00%)  1/803 (0.12%) 
Muscular Weakness * 1  0/398 (0.00%)  1/803 (0.12%) 
Musculoskeletal Chest Pain * 1  0/398 (0.00%)  2/803 (0.25%) 
Osteoarthritis * 1  0/398 (0.00%)  5/803 (0.62%) 
Osteonecrosis * 1  0/398 (0.00%)  1/803 (0.12%) 
Pain in Extremity * 1  1/398 (0.25%)  0/803 (0.00%) 
Pathological Fracture * 1  1/398 (0.25%)  0/803 (0.00%) 
Periarthritis * 1  1/398 (0.25%)  0/803 (0.00%) 
Periostitis * 1  0/398 (0.00%)  1/803 (0.12%) 
Polyarthritis * 1  0/398 (0.00%)  1/803 (0.12%) 
Polymyalgia Rheumatica * 1  1/398 (0.25%)  0/803 (0.00%) 
Pseudarthrosis * 1  0/398 (0.00%)  1/803 (0.12%) 
Spinal Flattening * 1  0/398 (0.00%)  1/803 (0.12%) 
Symphysiolysis * 1  0/398 (0.00%)  1/803 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of Colon * 1  0/398 (0.00%)  1/803 (0.12%) 
Benign Neoplasm of Bladder * 1  1/398 (0.25%)  0/803 (0.00%) 
Bladder Cancer * 1  1/398 (0.25%)  2/803 (0.25%) 
Colon Cancer * 1  1/398 (0.25%)  0/803 (0.00%) 
Colon Cancer Stage Ii * 1  0/398 (0.00%)  1/803 (0.12%) 
Gastric Cancer * 1  0/398 (0.00%)  2/803 (0.25%) 
Lung Neoplasm Malignant * 1  0/398 (0.00%)  2/803 (0.25%) 
Malignant Melanoma * 1  2/398 (0.50%)  0/803 (0.00%) 
Malignant Neoplasm of Renal Pelvis * 1  0/398 (0.00%)  1/803 (0.12%) 
Prostate Cancer Recurrent * 1  1/398 (0.25%)  0/803 (0.00%) 
Rectal Cancer * 1  1/398 (0.25%)  0/803 (0.00%) 
Renal Cell Carcinoma * 1  0/398 (0.00%)  1/803 (0.12%) 
Squamous Cell Carcinoma of Lung * 1  0/398 (0.00%)  1/803 (0.12%) 
Transitional Cell Carcinoma * 1  0/398 (0.00%)  2/803 (0.25%) 
Nervous system disorders     
Amnesia * 1  1/398 (0.25%)  0/803 (0.00%) 
Aphasia * 1  0/398 (0.00%)  2/803 (0.25%) 
Balance Disorder * 1  0/398 (0.00%)  1/803 (0.12%) 
Central Nervous System Lesion * 1  1/398 (0.25%)  0/803 (0.00%) 
Cerebellar Infarction * 1  1/398 (0.25%)  0/803 (0.00%) 
Cerebral Infarction * 1  1/398 (0.25%)  0/803 (0.00%) 
Cerebrovascular Accident * 1  1/398 (0.25%)  3/803 (0.37%) 
Dizziness * 1  0/398 (0.00%)  1/803 (0.12%) 
Haemorrhage Intracranial * 1  1/398 (0.25%)  0/803 (0.00%) 
Haemorrhagic Stroke * 1  0/398 (0.00%)  1/803 (0.12%) 
Headache * 1  0/398 (0.00%)  2/803 (0.25%) 
Ischaemic Stroke * 1  0/398 (0.00%)  1/803 (0.12%) 
Lacunar Stroke * 1  0/398 (0.00%)  1/803 (0.12%) 
Loss of Consciousness * 1  0/398 (0.00%)  1/803 (0.12%) 
Paraparesis * 1  1/398 (0.25%)  0/803 (0.00%) 
Polyneuropathy * 1  0/398 (0.00%)  1/803 (0.12%) 
Presyncope * 1  1/398 (0.25%)  0/803 (0.00%) 
Seizure * 1  0/398 (0.00%)  2/803 (0.25%) 
Spinal Cord Compression * 1  1/398 (0.25%)  0/803 (0.00%) 
Syncope * 1  1/398 (0.25%)  5/803 (0.62%) 
Thrombotic Cerebral Infarction * 1  0/398 (0.00%)  1/803 (0.12%) 
Transient Ischaemic Attack * 1  0/398 (0.00%)  3/803 (0.37%) 
Product Issues     
Device Occlusion * 1  0/398 (0.00%)  1/803 (0.12%) 
Psychiatric disorders     
Alcoholism * 1  1/398 (0.25%)  0/803 (0.00%) 
Anxiety * 1  0/398 (0.00%)  1/803 (0.12%) 
Confusional State * 1  0/398 (0.00%)  1/803 (0.12%) 
Delirium * 1  0/398 (0.00%)  1/803 (0.12%) 
Major Depression * 1  0/398 (0.00%)  1/803 (0.12%) 
Suicidal Ideation * 1  0/398 (0.00%)  1/803 (0.12%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  4/398 (1.01%)  6/803 (0.75%) 
Azotaemia * 1  0/398 (0.00%)  1/803 (0.12%) 
Bladder Mass * 1  1/398 (0.25%)  0/803 (0.00%) 
Bladder Neck Sclerosis * 1  1/398 (0.25%)  0/803 (0.00%) 
Bladder Necrosis * 1  0/398 (0.00%)  1/803 (0.12%) 
Calculus Urethral * 1  0/398 (0.00%)  1/803 (0.12%) 
Calculus Urinary * 1  1/398 (0.25%)  0/803 (0.00%) 
Cystitis Haemorrhagic * 1  0/398 (0.00%)  1/803 (0.12%) 
Dysuria * 1  0/398 (0.00%)  3/803 (0.37%) 
Haematuria * 1  8/398 (2.01%)  13/803 (1.62%) 
Hydronephrosis * 1  8/398 (2.01%)  8/803 (1.00%) 
Lower Urinary Tract Symptoms * 1  1/398 (0.25%)  0/803 (0.00%) 
Micturition Disorder * 1  0/398 (0.00%)  1/803 (0.12%) 
Pollakiuria * 1  0/398 (0.00%)  1/803 (0.12%) 
Renal Failure * 1  3/398 (0.75%)  3/803 (0.37%) 
Renal Impairment * 1  0/398 (0.00%)  1/803 (0.12%) 
Strangury * 1  0/398 (0.00%)  1/803 (0.12%) 
Ureteric Obstruction * 1  0/398 (0.00%)  1/803 (0.12%) 
Ureterolithiasis * 1  1/398 (0.25%)  1/803 (0.12%) 
Urethral Stenosis * 1  1/398 (0.25%)  2/803 (0.25%) 
Urinary Bladder Haemorrhage * 1  1/398 (0.25%)  0/803 (0.00%) 
Urinary Retention * 1  15/398 (3.77%)  10/803 (1.25%) 
Urinary Tract Obstruction * 1  4/398 (1.01%)  2/803 (0.25%) 
Reproductive system and breast disorders     
Prostatic Mass * 1  0/398 (0.00%)  1/803 (0.12%) 
Prostatitis * 1  0/398 (0.00%)  1/803 (0.12%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  0/398 (0.00%)  2/803 (0.25%) 
Chronic Obstructive Pulmonary Disease * 1  1/398 (0.25%)  0/803 (0.00%) 
Chronic Respiratory Failure * 1  0/398 (0.00%)  1/803 (0.12%) 
Dyspnoea * 1  1/398 (0.25%)  2/803 (0.25%) 
Epistaxis * 1  0/398 (0.00%)  1/803 (0.12%) 
Hypoxia * 1  1/398 (0.25%)  0/803 (0.00%) 
Lung Disorder * 1  0/398 (0.00%)  2/803 (0.25%) 
Pleural Effusion * 1  0/398 (0.00%)  1/803 (0.12%) 
Pneumonia Aspiration * 1  0/398 (0.00%)  1/803 (0.12%) 
Pulmonary Embolism * 1  1/398 (0.25%)  1/803 (0.12%) 
Pulmonary Oedema * 1  0/398 (0.00%)  1/803 (0.12%) 
Respiratory Failure * 1  0/398 (0.00%)  1/803 (0.12%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  0/398 (0.00%)  1/803 (0.12%) 
Erythema Multiforme * 1  0/398 (0.00%)  1/803 (0.12%) 
Granuloma Annulare * 1  0/398 (0.00%)  1/803 (0.12%) 
Vascular disorders     
Aortic Aneurysm * 1  0/398 (0.00%)  2/803 (0.25%) 
Arterial Occlusive Disease * 1  1/398 (0.25%)  0/803 (0.00%) 
Arteriosclerosis * 1  1/398 (0.25%)  1/803 (0.12%) 
Deep Vein Thrombosis * 1  0/398 (0.00%)  2/803 (0.25%) 
Haematoma * 1  0/398 (0.00%)  1/803 (0.12%) 
Hypertension * 1  3/398 (0.75%)  1/803 (0.12%) 
Hypertensive Crisis * 1  1/398 (0.25%)  0/803 (0.00%) 
Hypotension * 1  0/398 (0.00%)  2/803 (0.25%) 
Peripheral Arterial Occlusive Disease * 1  1/398 (0.25%)  0/803 (0.00%) 
Peripheral Ischaemia * 1  0/398 (0.00%)  1/803 (0.12%) 
Venous Aneurysm * 1  0/398 (0.00%)  1/803 (0.12%) 
Venous Thrombosis * 1  0/398 (0.00%)  1/803 (0.12%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Apalutamide
Affected / at Risk (%) Affected / at Risk (%)
Total   329/398 (82.66%)   716/803 (89.17%) 
Blood and lymphatic system disorders     
Anaemia * 1  15/398 (3.77%)  51/803 (6.35%) 
Endocrine disorders     
Hypothyroidism * 1  5/398 (1.26%)  48/803 (5.98%) 
Gastrointestinal disorders     
Abdominal Discomfort * 1  22/398 (5.53%)  37/803 (4.61%) 
Abdominal Pain * 1  33/398 (8.29%)  64/803 (7.97%) 
Abdominal Pain Upper * 1  32/398 (8.04%)  44/803 (5.48%) 
Constipation * 1  52/398 (13.07%)  87/803 (10.83%) 
Diarrhoea * 1  60/398 (15.08%)  159/803 (19.80%) 
Dyspepsia * 1  22/398 (5.53%)  58/803 (7.22%) 
Nausea * 1  63/398 (15.83%)  145/803 (18.06%) 
Vomiting * 1  24/398 (6.03%)  43/803 (5.35%) 
General disorders     
Asthenia * 1  33/398 (8.29%)  89/803 (11.08%) 
Fatigue * 1  84/398 (21.11%)  244/803 (30.39%) 
Oedema Peripheral * 1  29/398 (7.29%)  68/803 (8.47%) 
Infections and infestations     
Nasopharyngitis * 1  25/398 (6.28%)  78/803 (9.71%) 
Upper Respiratory Tract Infection * 1  21/398 (5.28%)  44/803 (5.48%) 
Urinary Tract Infection * 1  37/398 (9.30%)  57/803 (7.10%) 
Injury, poisoning and procedural complications     
Fall * 1  35/398 (8.79%)  121/803 (15.07%) 
Investigations     
Weight Decreased * 1  25/398 (6.28%)  128/803 (15.94%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  35/398 (8.79%)  99/803 (12.33%) 
Hypercholesterolaemia * 1  6/398 (1.51%)  49/803 (6.10%) 
Hyperglycaemia * 1  15/398 (3.77%)  44/803 (5.48%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  30/398 (7.54%)  128/803 (15.94%) 
Back Pain * 1  59/398 (14.82%)  100/803 (12.45%) 
Pain in Extremity * 1  20/398 (5.03%)  73/803 (9.09%) 
Nervous system disorders     
Dizziness * 1  25/398 (6.28%)  74/803 (9.22%) 
Dysgeusia * 1  6/398 (1.51%)  57/803 (7.10%) 
Headache * 1  25/398 (6.28%)  75/803 (9.34%) 
Psychiatric disorders     
Insomnia * 1  21/398 (5.28%)  55/803 (6.85%) 
Renal and urinary disorders     
Dysuria * 1  22/398 (5.53%)  41/803 (5.11%) 
Haematuria * 1  34/398 (8.54%)  60/803 (7.47%) 
Nocturia * 1  29/398 (7.29%)  39/803 (4.86%) 
Pollakiuria * 1  34/398 (8.54%)  45/803 (5.60%) 
Urinary Incontinence * 1  15/398 (3.77%)  42/803 (5.23%) 
Urinary Retention * 1  24/398 (6.03%)  28/803 (3.49%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  28/398 (7.04%)  58/803 (7.22%) 
Dyspnoea * 1  15/398 (3.77%)  63/803 (7.85%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  6/398 (1.51%)  50/803 (6.23%) 
Rash * 1  13/398 (3.27%)  87/803 (10.83%) 
Rash Maculo-Papular * 1  2/398 (0.50%)  43/803 (5.35%) 
Vascular disorders     
Hot Flush * 1  34/398 (8.54%)  113/803 (14.07%) 
Hypertension * 1  77/398 (19.35%)  198/803 (24.66%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
These results are up to clinical cutoff (CCO) date (that is, 19 May 2017).
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
Name/Title: Senior Medical Director, WC Clinical Oncology Department
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
Responsible Party: Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01946204     History of Changes
Other Study ID Numbers: CR102931
ARN-509-003 ( Other Identifier: Aragon Pharmaceuticals, Inc. )
2012-004322-24 ( EudraCT Number )
First Submitted: September 17, 2013
First Posted: September 19, 2013
Results First Submitted: May 18, 2018
Results First Posted: June 19, 2018
Last Update Posted: September 21, 2018