Trial Outcomes & Findings for Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy (NCT NCT02217566)

Last Updated: 2020-01-13

Results Overview

Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (\>=) 25 percent (%) and \>=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is \>=25% and \>=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2020-01-13

Participant Flow

A total of 46 participants were enrolled into the study and were treated with abiraterone acetate and prednisone. Out of 46 participants, 6 did not fulfill all eligibility criteria and included in the safety population. Thirty-five (35) participants completed the study.

Participant milestones

Participant milestones
Measure	Abiraterone Acetate Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Overall Study STARTED	46
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Abiraterone Acetate Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Overall Study Lost to Follow-up	2
Overall Study Death	3
Overall Study Early study termination	6

Baseline Characteristics

Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abiraterone Acetate n=46 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Age, Continuous	68.8 years STANDARD_DEVIATION 7.71 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	46 Participants n=93 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	1 Participants n=93 Participants
Race/Ethnicity, Customized Black or African/South American	7 Participants n=93 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants
Race/Ethnicity, Customized White/Caucasian	37 Participants n=93 Participants
Region of Enrollment BRAZIL	46 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: The efficacy population included all eligible participants who received at least one dose of any study drug.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=40 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Time to Prostate-specific Antigen (PSA) Progression	7.3 Months Interval 5.6 to 10.0

SECONDARY outcome

Timeframe: Week 12 to any time up to 2 years

Population: The efficacy population included all eligible participants who received at least one dose of any study drug.

The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=40 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response	57.50 Percentage of participants Interval 27.0 to 59.1

SECONDARY outcome

Timeframe: Up to 4 years

Population: The efficacy population included all eligible participants who received at least one dose of any study drug.

Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=40 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Overall Survival	29.6 Months Interval 16.1 to Here, NA signifies that the number of participants with events was not sufficient to provide upper confidence limit estimate for median as curve representing upper confidence limits for survival function lies above 0.50.

SECONDARY outcome

Timeframe: Up to 2 years

Population: The efficacy population included all eligible participants who received at least one dose of any study drug and with at least 2 BPI-SF assessments after baseline.

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=36 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score	19.44 Percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: The efficacy population included all eligible participants who received at least one dose of any study drug and with at least 2 BPI-SF assessments after baseline.

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=33 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score	15.15 Percentage of participants

SECONDARY outcome

Timeframe: Up to 4 years

Population: The safety population included all participants who received at least 1 dose of any study drug.

An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate n=46 Participants Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AEs	45 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAEs	11 Participants

Adverse Events

Abiraterone Acetate

Serious events: 11 serious events

Other events: 45 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Abiraterone Acetate n=46 participants at risk Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac Failure	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardio-Respiratory Arrest	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Amaurosis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastrointestinal Obstruction	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Rectal Haemorrhage	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Asthenia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Cystitis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Sepsis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary Tract Infection	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Fall	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Femur Fracture	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Ulna Fracture	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperkalaemia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebrovascular Accident	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dysarthria	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Spinal Cord Compression	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Tremor	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Delirium	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Nephrolithiasis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Aspiration	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.

Other adverse events

Other adverse events
Measure	Abiraterone Acetate n=46 participants at risk Participants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
Blood and lymphatic system disorders Anaemia	28.3% 13/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Eosinophilia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Lymphopenia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Neutropenia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombocytopenia	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrial Fibrillation	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrioventricular Block	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Bundle Branch Block Left	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac Failure	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac Failure Congestive	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Cardiac disorders Sinus Tachycardia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Endocrine disorders Hypothyroidism	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Conjunctival Haemorrhage	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Eye Pain	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Glaucoma	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Ocular Hyperaemia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Papilloedema	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Eye disorders Vision Blurred	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal Discomfort	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal Pain	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal Pain Lower	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal Pain Upper	17.4% 8/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal Wall Haematoma	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Anal Incontinence	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Anorectal Discomfort	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Aphthous Ulcer	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Constipation	21.7% 10/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diarrhoea	19.6% 9/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diverticulum	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dry Mouth	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dyspepsia	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Flatulence	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Haematochezia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	23.9% 11/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Odynophagia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Proctalgia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	26.1% 12/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Asthenia	17.4% 8/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Chest Pain	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Face Oedema	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Fatigue	32.6% 15/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Influenza Like Illness	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Localised Oedema	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Malaise	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Mucosal Inflammation	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Oedema Peripheral	19.6% 9/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
General disorders Pyrexia	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Hyperbilirubinaemia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Anal Abscess	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Gastroenteritis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Influenza	15.2% 7/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Nasopharyngitis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Paronychia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Rhinitis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Sinusitis	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Strongyloidiasis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Subcutaneous Abscess	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Upper Respiratory Tract Infection	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary Tract Infection	15.2% 7/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Eye Injury	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Fall	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Infusion Related Reaction	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Joint Injury	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Sciatic Nerve Injury	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Tooth Fracture	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Alanine Aminotransferase Increased	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Aspartate Aminotransferase Increased	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Blood Alkaline Phosphatase Increased	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Blood Bilirubin Increased	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Blood Creatinine Increased	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Blood Lactate Dehydrogenase Increased	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Blood Pressure Increased	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations ECG Electrically Inactive Area	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations International Normalised Ratio	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Platelet Count Decreased	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Weight Decreased	13.0% 6/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations Weight Increased	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Investigations White Blood Cell Count Decreased	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased Appetite	23.9% 11/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	37.0% 17/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperkalaemia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypokalaemia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Metabolic Acidosis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Vitamin B12 Deficiency	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Vitamin D Deficiency	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	26.1% 12/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back Pain	45.7% 21/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bone Pain	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Coccydynia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Groin Pain	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscular Weakness	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	10.9% 5/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Neck Pain	10.9% 5/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis of Jaw	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteopenia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	26.1% 12/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Spinal Pain	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebrovascular Accident	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	23.9% 11/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Motor Dysfunction	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Neuropathy Peripheral	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Paraesthesia	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Syncope	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Nervous system disorders Tremor	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Anxiety	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Depression	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Insomnia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Dysuria	19.6% 9/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	13.0% 6/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Lower Urinary Tract Symptoms	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal Failure	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Urethral Haemorrhage	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Urethral Pain	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Urinary Retention	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Gynaecomastia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Pelvic Pain	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Penile Burning Sensation	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Cough	21.7% 10/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 4/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Nasal Obstruction	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Productive Cough	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Tracheal Pain	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Irritation	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Alopecia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dry Skin	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.5% 3/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Petechiae	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Pruritus	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Flushing	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Haematoma	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hyperaemia	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	41.3% 19/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypotension	4.3% 2/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Shock	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.
Vascular disorders Varicose Vein	2.2% 1/46 • Up to 4 years Safety population included all participants who received at least 1 dose of any study drug.

Additional Information

Regional Medical Affairs Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER