Trial Outcomes & Findings for An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy (NCT NCT00474383)
NCT ID: NCT00474383
Last Updated: 2014-05-12
Results Overview
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2014-05-12
Participant Flow
The 5 participants in the Extension Study received treatment until they experienced progressive disease.
Participant milestones
| Measure |
Abiraterone Acetate (Main Study)
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
Arbitarone Acetate (Extension)
Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
|
|---|---|---|
|
Main Study
STARTED
|
47
|
0
|
|
Main Study
COMPLETED
|
11
|
0
|
|
Main Study
NOT COMPLETED
|
36
|
0
|
|
Between Main Study and Extension
STARTED
|
11
|
0
|
|
Between Main Study and Extension
COMPLETED
|
5
|
0
|
|
Between Main Study and Extension
NOT COMPLETED
|
6
|
0
|
|
Extension
STARTED
|
0
|
5
|
|
Extension
COMPLETED
|
0
|
0
|
|
Extension
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate (Main Study)
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
Arbitarone Acetate (Extension)
Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
|
|---|---|---|
|
Main Study
Adverse Event
|
11
|
0
|
|
Main Study
Symptomatic Deterioration
|
1
|
0
|
|
Main Study
Progressive Disease
|
23
|
0
|
|
Main Study
Other
|
1
|
0
|
|
Between Main Study and Extension
Did Not Enter Extension Phase
|
6
|
0
|
|
Extension
Progressive Disease
|
0
|
5
|
Baseline Characteristics
An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 8.42 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Outcome measures
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
|
36.2 percentage of participants
Interval 22.7 to 51.5
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Outcome measures
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response
|
44.7 percentage of participants
Interval 30.2 to 59.9
|
SECONDARY outcome
Timeframe: Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)Population: The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.
The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.
Outcome measures
| Measure |
Abiraterone Acetate
n=23 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
SECONDARY outcome
Timeframe: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)Population: The ITT population included all the participants who were enrolled into the study.
The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Outcome measures
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Time to PSA Progression
|
169 days
Interval 113.0 to 281.0
|
SECONDARY outcome
Timeframe: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)Population: The ITT population included all the participants who were enrolled into the study.
Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Outcome measures
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Duration of PSA Response
|
169 days
Interval 141.0 to 262.0
|
SECONDARY outcome
Timeframe: Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)Population: The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.
Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Abiraterone Acetate
n=23 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Progression Free Survival Time
|
457 days
Interval 163.0 to 712.0
|
SECONDARY outcome
Timeframe: Baseline until death, or end of study (Week 148)Population: The ITT population included all the participants who were enrolled into the study.
Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
Outcome measures
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Overall Survival
|
380 days
Interval 311.0 to 457.0
|
SECONDARY outcome
Timeframe: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)Population: The ITT population included all the participants who were enrolled into the study.
The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair \>50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.
Outcome measures
| Measure |
Abiraterone Acetate
n=47 Participants
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Baseline, ECOG 0
|
16 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Baseline, ECOG 1
|
27 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Baseline, ECOG 2
|
4 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Best Post-Baseline. ECOG 0
|
25 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Best Post-Baseline. ECOG 1
|
19 participants
|
|
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Best Post-Baseline. ECOG 2
|
3 participants
|
Adverse Events
Abiraterone Acetate
Serious events: 27 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone Acetate
n=47 participants at risk
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.6%
5/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Cardiac disorders
Left ventricular dysfunction
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Cardiac disorders
Myocardial infarction
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Asthenia
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Disease progression
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Fatigue
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Influenza like illness
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Pitting oedema
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Pyrexia
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Bronchopneumonia
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Sepsis
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Urosepsis
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Transaminases increased
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Anorexia
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
4.3%
2/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Vascular disorders
Hypertension
|
2.1%
1/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
Other adverse events
| Measure |
Abiraterone Acetate
n=47 participants at risk
Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.1%
9/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
23.4%
11/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
23.4%
11/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
21.3%
10/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
10/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Fatigue
|
53.2%
25/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
General disorders
Oedema peripheral
|
27.7%
13/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Cellulitis
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Tooth infection
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
17.0%
8/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Injury, poisoning and procedural complications
Contusion
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Blood albumin decreased
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Blood creatine increased
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Blood sodium increased
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Weight decreased
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
Weight increased
|
12.8%
6/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Investigations
White blood cell count decreased
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Anorexia
|
27.7%
13/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.9%
7/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
61.7%
29/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.8%
14/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.1%
9/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
19.1%
9/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.6%
5/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
19.1%
9/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.8%
6/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Dizziness
|
10.6%
5/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Headache
|
12.8%
6/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Hypoaesthesia
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Psychiatric disorders
Insomnia
|
8.5%
4/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
6.4%
3/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
7/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.9%
7/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.6%
5/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
|
Vascular disorders
Hypertension
|
21.3%
10/47 • From the first dose of study medication until 30 days after the last dose of study medication
|
Additional Information
Senior Director
Clinical Research, Janssen R&D, 10990 Wilshire Blvd, Suite 1200, Los Angeles, CA 90024.
Phone: 310-943-8040
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60