Trial Outcomes & Findings for Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer (NCT NCT03098836)

NCT ID: NCT03098836

Last Updated: 2025-09-12

Results Overview

Radiographic PFS based on PCWG2 criteria or based on the onset of a skeletal related event. Imaging obtained every 12 weeks. Kaplan-Meier estimate of percentage of participants is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 93 participants
• Primary outcome timeframe: every 12 weeks, up to 2 years
• Results posted on: 2025-09-12

Participant Flow

Participant milestones

Measure	Caucasian Self-identified Caucasian patients with mCRPC	African American Self-identified African American patients with mCRPC
Overall Study STARTED	50	43
Overall Study COMPLETED	14	22
Overall Study NOT COMPLETED	36	21

Reasons for withdrawal

Measure	Caucasian Self-identified Caucasian patients with mCRPC	African American Self-identified African American patients with mCRPC
Overall Study Adverse Event	1	3
Overall Study Lack of Efficacy	30	15
Overall Study Physician Decision	2	1
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC	Total n=93 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 7 • n=93 Participants	70 years STANDARD_DEVIATION 9 • n=4 Participants	70 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	50 Participants n=93 Participants	43 Participants n=4 Participants	93 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=93 Participants	43 Participants n=4 Participants	93 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	43 Participants n=4 Participants	43 Participants n=27 Participants
Race (NIH/OMB) White	50 Participants n=93 Participants	0 Participants n=4 Participants	50 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	50 participants n=93 Participants	43 participants n=4 Participants	93 participants n=27 Participants

PRIMARY outcome

Timeframe: every 12 weeks, up to 2 years

Radiographic PFS based on PCWG2 criteria or based on the onset of a skeletal related event. Imaging obtained every 12 weeks. Kaplan-Meier estimate of percentage of participants is reported.

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
Percentage of Participants With 2-Year Progression-Free Survival (PFS)	38 Percentage of participants Interval 27.0 to 55.0	61 Percentage of participants Interval 48.0 to 78.0

SECONDARY outcome

Timeframe: every 4 weeks, up to 2 years

PSA progression-free survival

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
2-year PSA Progression Free Survival	38 percent Interval 24.0 to 58.0	60 percent Interval 46.0 to 80.0

SECONDARY outcome

Timeframe: every 4 weeks, up to 2 years

Time to PSA nadir

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
Time to PSA Nadir	1.9 months Interval 1.0 to 5.5	5.3 months Interval 1.8 to 8.3

SECONDARY outcome

Timeframe: every 4 weeks, up to 2 years

Percent of men who achieve a PSA < 0.1

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
Percent of Men Who Achieve a PSA < 0.1	26 percent of participant	40 percent of participant

SECONDARY outcome

Timeframe: every 12 weeks, up to 2 years

Population: Four patients were unevaluable. Two patients did not have response recorded.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT: Complete Response (CR), disappearance of all lesions and any pathologic lymph nodes (target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR), ≥30% decrease in the sum diameter of target lesions as compared to the baseline sum diameter; Overall Response (OR) = CR + PR

Outcome measures

Measure	Caucasian n=46 Participants Self-identified Caucasian patients with mCRPC	African American n=41 Participants Self-identified African American patients with mCRPC
Radiologic Response Rates	10 percent	14 percent

SECONDARY outcome

Timeframe: 12 weeks

Percentage of participants who experienced bone flares per radiographic assessments

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
Percentage of Participants With Bone Flares	16 percent	9 percent

SECONDARY outcome

Timeframe: up to 2 years

Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. Grade assessed according to NCI CTC v4.0 with higher grade being worse is reported.

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
Percentage of Participants With Hypertension Grade 2 hypertension	40 percent of participants	40 percent of participants
Percentage of Participants With Hypertension Grade 3 hypertension	16 percent of participants	14 percent of participants
Percentage of Participants With Hypertension Grade 4 hypertension	0 percent of participants	2 percent of participants

SECONDARY outcome

Timeframe: every 6 months, up to 82 months

Survival of subjects over the time the study is ongoing

Outcome measures

Measure	Caucasian n=50 Participants Self-identified Caucasian patients with mCRPC	African American n=43 Participants Self-identified African American patients with mCRPC
Median Overall Survival	36 months Interval 30.0 to 60.0	72 months Interval 44.0 to Upper confidence interval limit not estimable due to insufficient number of participants with events

Adverse Events

Caucasian

Serious events: 12 serious events

Other events: 50 other events

Deaths: 34 deaths

African American

Serious events: 10 serious events

Other events: 43 other events

Deaths: 20 deaths

Serious adverse events

Measure	Caucasian n=50 participants at risk Self-identified Caucasian patients with mCRPC	African American n=43 participants at risk Self-identified African American patients with mCRPC
Cardiac disorders Coronary Artery Blockage x4	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Myocardial infarction	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Ventricular tachycardia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Atrial fibrillation	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Heart failure	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Encephalitis infection	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Fall	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications CLOSED FRACTURE, HEAD	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Study Drug Overdose	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Platelet count decreased	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Dehydration	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders RHABDOMYOLSIS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastatic castration-resistant prostate cancer	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders Dizziness	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders Intracranial hemorrhage	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders Seizure	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders Stroke	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders Syncope	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Renal calculi	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Multifocal Pneumonia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures LAPAROSCOPIC COLECTOMY FOR COLON CANCER	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders Hypertension	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Arrhythmia	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.

Other adverse events

Measure	Caucasian n=50 participants at risk Self-identified Caucasian patients with mCRPC	African American n=43 participants at risk Self-identified African American patients with mCRPC
Blood and lymphatic system disorders Anemia	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	16.3% 7/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Atrial fibrillation	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders BRADYCARDIA	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Chest pain - cardiac	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Palpitations	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders Sinus tachycardia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Ear and labyrinth disorders Tinnitus	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Ear and labyrinth disorders Vertigo	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Ear and labyrinth disorders Ear pain	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Endocrine disorders Hypothyroidism	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	11.6% 5/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Endocrine disorders Hyperthyroidism	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Blurred vision	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Dry eye	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders DANDRUFF	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Photophobia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Uveitis	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Cataract	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Floaters	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Retinopathy	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Eye disorders Watering eyes	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Abdominal pain	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Ascites	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Bloating	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Constipation	14.0% 7/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	18.6% 8/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Diarrhea	22.0% 11/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	18.6% 8/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Dry mouth	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Dyspepsia	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Dysphagia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Flatulence	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Mucositis oral	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Nausea	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	23.3% 10/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Oral dysesthesia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Stomach pain	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Vomiting	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	16.3% 7/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Colitis	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Fecal incontinence	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Hemorrhoids	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Lip pain	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Oral pain	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Edema limbs	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Fatigue	54.0% 27/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	44.2% 19/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Fever	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Gait disturbance	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Irritability	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Localized edema	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Non-cardiac chest pain	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Pain	20.0% 10/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	20.9% 9/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Chills	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Edema face	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Facial pain	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Flu like symptoms	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Injection site reaction	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders Malaise	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Bronchial infection	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Nail infection	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Papulopustular rash	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Rash pustular	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Sinusitis	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Upper respiratory infection	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Urinary tract infection	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Lung infection	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Otitis media	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations Skin infection	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Ankle fracture	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Bruising	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Fall	14.0% 7/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Fracture	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Alanine aminotransferase increased	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Alkaline phosphatase increased	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Aspartate aminotransferase increased	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Blood bilirubin increased	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Cholesterol high	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Lymphocyte count decreased	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Neutrophil count decreased	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	16.3% 7/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Platelet count decreased	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Weight loss	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	18.6% 8/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations White blood cell decreased	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Creatinine increased	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations Weight gain	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Anorexia	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	18.6% 8/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Dehydration	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Glucose intolerance	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypercalcemia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hyperglycemia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	20.9% 9/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hyperkalemia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypoalbuminemia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypocalcemia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypokalemia	30.0% 15/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	53.5% 23/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypomagnesemia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hyponatremia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypophosphatemia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Arthritis	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Back pain	18.0% 9/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	18.6% 8/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Buttock pain	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Chest wall pain	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Flank pain	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Neck pain	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Osteoporosis	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 10/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	30.2% 13/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Amnesia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Cognitive disturbance	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Concentration impairment	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Dizziness	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	14.0% 6/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Dysarthria	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Dysgeusia	14.0% 7/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Headache	12.0% 6/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	16.3% 7/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Intracranial hemorrhage	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Memory impairment	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Paresthesia	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Presyncope	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Seizure	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Somnolence	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Spasticity	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Tremor	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Extrapyramidal disorder	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Neuralgia	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Peripheral sensory neuropathy	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Syncope	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Pregnancy, puerperium and perinatal conditions Transient ischemic attacks	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Psychiatric disorders Agitation	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Psychiatric disorders Anxiety	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Psychiatric disorders Confusion	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Psychiatric disorders Depression	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Psychiatric disorders Insomnia	14.0% 7/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	9.3% 4/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Psychiatric disorders Hallucinations	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Hematuria	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Renal calculi	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Renal colic	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Urinary frequency	12.0% 6/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	11.6% 5/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Urinary incontinence	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Urinary retention	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Urine discoloration	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Chronic kidney disease	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Urinary tract pain	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders Urinary urgency	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Reproductive system and breast disorders Gynecomastia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Reproductive system and breast disorders Pelvic pain	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Reproductive system and breast disorders Testicular pain	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Cough	12.0% 6/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	16.3% 7/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Hiccups	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 5/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Postnasal drip	6.0% 3/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Sleep apnea	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Sore throat	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Wheezing	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Nail ridging	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Pruritus	8.0% 4/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Rash acneiform	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.0% 6/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	11.6% 5/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Skin induration	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders Flushing	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders Hot flashes	16.0% 8/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders Hypertension	56.0% 28/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	55.8% 24/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders Hypotension	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders Thromboembolic event	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders PULMONARY ARTERY EMBOLISM, CT CHEST FINDINGS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders PREMATURE VENTRICULAR CONTRACTIONS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders ELEVATED HEART RATE	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders EXCESSIVE SALIVA	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders CANKER SORES IN MOUTH	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders TONGUE ULCERS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Gastrointestinal disorders MILD DIVERTICULITIS OF DESCENDING COLON AND SIGMOID COLON	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders PAIN, SHOULDERS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders MEDICATION OVERDOSE	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	7.0% 3/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders ACCIDENTAL OVERDOSE	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders EDEMA	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders HAIR LOSS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders HEAD PAIN	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders POSTERIOR BILATERAL PELVIC ACHES	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders VIVID DREAMS	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders FEELING "WIRED"	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Nervous system disorders SPINAL CORD COMPRESSION	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders COLD LIKE SYMPTOMS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures HAMMER TOE CORRECTION	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures SKIN BIOPSIES	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures LYMPH NODE BIOPSY	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures MOH'S PROCEDURE ON NOSE	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures LEFT HIP ARTHROPLASTY	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures L - EXTRACTION CATARACT EXTRACAPSULAR WITH PHACO WITH INSERTION INTRAOCULAR PROSTHESIS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures RIGHT INTERNAL CAROTID ARTERY STENT	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures PROVENGE INFUSION	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures CYSTOURETHROSCOPY, WITH INSERTION OF INDWELLING STENT, UROGRAPHY RETROGRADE	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Surgical and medical procedures MOHS SURGERY	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Vascular disorders TRANSIENT HYPERTENSION INCREASE RELATED TO BENADRYL	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Cardiac disorders NONSUSTAINED VENTRICULAR TACHYCARDIA	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations PNEUMONIA	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations ERYTHEMA OF FACE; OCCURS WITH FEVER	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations NON FASTING GLUCOSE ELEVATED	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations HYPERLIPIDEMIA	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders URINE ODOR	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders STRONG URINE ODOR	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders MALODOROUS URINE	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders URINARY HESITANCY	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders URETER SPASM	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders INTERMITTENT BURNING WITH URINATION	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders INTERMITTENT SULFUR SMELL AFTER TAKING APALUTAMIDE	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders NOCTURIA	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders INGROWN TOENAIL	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders BOILS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders NASAL SORES	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders NAIL THINNING	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders RASH	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders PIMPLE ON SCROTUM	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders BUMP ON R AND L BUTTOCKS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders DARK UNDER EYE CIRCLES	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders CHILL ON BACK AND LEGS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders RASH, RIGHT WRIST AND UPPER ARM	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders SKIN LESION CAUTERIZATION	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders DERMATOSIS PAPULOSANIGRA	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders LEFT FOREARM LACERATION	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders BILATERAL FOOT CALLOUS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders DISCOLORED HANDS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Infections and infestations COVID-19	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	4.7% 2/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Endocrine disorders INT NIGHT SWEATS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Endocrine disorders ELEVATED TSH	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Renal and urinary disorders ELEVATED CREATININE	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders RASH RIGHT WRIST AND UPPER ARM	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders PRURITIC HYPERPIGMENTED LESION ON BACK	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders DISCOLORATION IN HANDS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders RASH ON TORSO	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Skin and subcutaneous tissue disorders HAIR LOSS ON CHEST	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders LEFT KNEE NUMBNESS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
General disorders LEFT BIG TOE TENDERNESS	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations TSH ELEVATED	4.0% 2/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations COVID	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Investigations PSA INCREASED (8.41)	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders PULLED GROIN MUSCLE	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders CRAMPING IN HANDS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders INTERMITTENT BILATERAL HAND AND FOOT CRAMPS	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders LEFT JAW CLICKING	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders SHOULDER TENDERNESS L	0.00% 0/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	2.3% 1/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders CHEST CONGESTION	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders LEFT SHOULDER	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders RESTLESS LEG SYNDROME	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.
Musculoskeletal and connective tissue disorders RIGHT HIP PAIN	2.0% 1/50 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.	0.00% 0/43 • up to 2 years, while participant was receiving study drugs; all-cause mortality was collected throughout the follow-up period (up to 82 months) The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0.

Additional Information

Daniel George, MD

Duke University Medical Center

Phone: (919) 668-8108

Email: daniel.george@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place