Trial Outcomes & Findings for Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies (NCT NCT01254864)

NCT ID: NCT01254864

Last Updated: 2025-01-27

Results Overview

Time to treatment failure (TTF), defined as time from randomization (AP+S or AP+D) to progression per PCWG2 criteria or death.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 190 participants
• Primary outcome timeframe: Up to 11 months
• Results posted on: 2025-01-27

Participant Flow

From March 2011 to February 2015, patients were recruited from the outpatient clinics of Genitourinay Medical Oncology at MD Anderson Cancer Center in Houston, TX who have been diagnosed with metastatic prostate cancer.

190 subjects were assessed for eligibility however of those 190 subjects, 10 did not meet eligibility criteria and 1 declined participation. A total of 179 subjects started on trial and received Abiraterone Acetate + Prednisone (AP). Of the 179 subjects that started on trial, 132 were randomized to the combination arms (64 to AP + Sunitinib and 68 to AP + Dasatinib).

Participant milestones

Measure	Abiraterone Acetate + Prednisone (AP) Abiraterone Acetate at 1000mg orally each day, given in combination with 5mg of Prednisone orally twice daily	AP + Sunitinib AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.	AP + Dasatinib AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.
Abiraterone Acetate+Prednisone(AP) Phase STARTED	179	0	0
Abiraterone Acetate+Prednisone(AP) Phase Randomized to AP + Sunitinib	64	0	0
Abiraterone Acetate+Prednisone(AP) Phase Randomized to AP + Dasatinib	68	0	0
Abiraterone Acetate+Prednisone(AP) Phase Crossover to AP + Sunitinib	0	0	0
Abiraterone Acetate+Prednisone(AP) Phase Crossover to AP + Dasatanib	0	0	0
Abiraterone Acetate+Prednisone(AP) Phase COMPLETED	132	0	0
Abiraterone Acetate+Prednisone(AP) Phase NOT COMPLETED	47	0	0
Randomization Phase STARTED	0	64	68
Randomization Phase Crossover to AP + Sunitinib	0	0	32
Randomization Phase Crossover to AP + Dasatanib	0	39	0
Randomization Phase COMPLETED	0	31	22
Randomization Phase NOT COMPLETED	0	33	46

Reasons for withdrawal

Measure	Abiraterone Acetate + Prednisone (AP) Abiraterone Acetate at 1000mg orally each day, given in combination with 5mg of Prednisone orally twice daily	AP + Sunitinib AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.	AP + Dasatinib AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.
Abiraterone Acetate+Prednisone(AP) Phase Adverse Event	4	0	0
Abiraterone Acetate+Prednisone(AP) Phase Death	1	0	0
Abiraterone Acetate+Prednisone(AP) Phase Physician Decision	24	0	0
Abiraterone Acetate+Prednisone(AP) Phase Withdrawal by Subject	9	0	0
Abiraterone Acetate+Prednisone(AP) Phase Non-compliance	2	0	0
Abiraterone Acetate+Prednisone(AP) Phase Ongoing Response to Abiraterone	7	0	0
Randomization Phase Adverse Event	0	5	17
Randomization Phase Death	0	1	0
Randomization Phase Lost to Follow-up	0	0	1
Randomization Phase Physician Decision	0	20	25
Randomization Phase Withdrawal by Subject	0	4	2
Randomization Phase Non-Compliance	0	1	0
Randomization Phase Comorbidities	0	2	1

Baseline Characteristics

Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies

Baseline characteristics by cohort

Measure	Abiraterone Acetate + Prednisone (AP) n=179 Participants Abiraterone Acetate at 1000mg orally each day, given in combination with 5mg of Prednisone orally twice daily	AP + Sunitinib AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.	AP + Dasatinib AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.	Total n=179 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants	—	—	84 Participants n=4 Participants
Age, Categorical >=65 years	95 Participants n=5 Participants	—	—	95 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Sex: Female, Male Male	179 Participants n=5 Participants	—	—	179 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	—	—	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants	—	—	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	96 Participants n=5 Participants	—	—	96 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	—	—	19 Participants n=4 Participants
Race (NIH/OMB) White	146 Participants n=5 Participants	—	—	146 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	—	—	11 Participants n=4 Participants
Region of Enrollment United States	179 participants n=5 Participants	—	—	179 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 11 months

Population: The first group/arm was not reported as the outcome measure of time to treatment failure is defined as the time from randomization (subjects were randomized after being in the first group/arm) to progression.

Time to treatment failure (TTF), defined as time from randomization (AP+S or AP+D) to progression per PCWG2 criteria or death.

Outcome measures

Measure	Abiraterone Acetate + Prednisone (AP) Abiraterone Acetate at 1000mg orally each day, given in combination with 5mg of Prednisone orally twice daily	AP + Sunitinib n=64 Participants AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.	AP + Dasatinib n=68 Participants AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.
Time to Treatment Failure (TTF)	—	5.5 Months Interval 4.6 to 6.8	5.7 Months Interval 3.8 to 7.4

Adverse Events

Abiraterone Acetate + Prednisone (AP)

Serious events: 8 serious events

Other events: 46 other events

Deaths: 0 deaths

AP + Sunitinib

Serious events: 11 serious events

Other events: 33 other events

Deaths: 1 deaths

AP + Sunitinib → AP + Dasatanib

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

AP + Dasatinib

Serious events: 10 serious events

Other events: 43 other events

Deaths: 0 deaths

AP + Dasatanib → AP + Sunitinib

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Abiraterone Acetate + Prednisone (AP) n=179 participants at risk Abiraterone Acetate at 1000mg orally each day, given in combination with 5mg of Prednisone orally twice daily	AP + Sunitinib n=64 participants at risk AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.	AP + Sunitinib → AP + Dasatanib n=39 participants at risk Randomized from AP group to receive AP + Sunitinib now on crossover group to receive AP + Dasatinib due to further disease progression.	AP + Dasatinib n=68 participants at risk AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.	AP + Dasatanib → AP + Sunitinib n=32 participants at risk Randomized from AP group to receive AP + Dasatanib now on crossover group to receive AP + Sunitinib due to further disease progression.
Metabolism and nutrition disorders Hyponatremia	0.56% 1/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Diarrhea	0.56% 1/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Dehydration	1.1% 2/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Facial Pain	0.56% 1/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Fever	1.1% 2/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Bone Pain	0.56% 1/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Infections and infestations Lung Infection	0.56% 1/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Cardiac disorders Chest Pain-Cardiac	0.56% 1/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Cardiac disorders Cardiac disorders- other	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.6% 1/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	2.9% 2/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Hematuria	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	3.1% 2/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Spinal Fracture	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.6% 1/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	3.1% 2/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Syncope	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	3.1% 2/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Fall	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.6% 1/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Dizziness	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Headaches	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	2.9% 2/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Surgical and medical procedures Surgical and medical procedures - other	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Infections and infestations Urinary Tract Infection	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Infections and infestations Sepsis	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Cardiac disorders Myocardial Infarction	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	1.5% 1/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.

Other adverse events

Measure	Abiraterone Acetate + Prednisone (AP) n=179 participants at risk Abiraterone Acetate at 1000mg orally each day, given in combination with 5mg of Prednisone orally twice daily	AP + Sunitinib n=64 participants at risk AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression.	AP + Sunitinib → AP + Dasatanib n=39 participants at risk Randomized from AP group to receive AP + Sunitinib now on crossover group to receive AP + Dasatinib due to further disease progression.	AP + Dasatinib n=68 participants at risk AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression.	AP + Dasatanib → AP + Sunitinib n=32 participants at risk Randomized from AP group to receive AP + Dasatanib now on crossover group to receive AP + Sunitinib due to further disease progression.
Gastrointestinal disorders Abdominal Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Activated Partial Thromboplastin Time Prolonged	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Alanine Aminotransferase Increased	6.1% 11/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	14.1% 9/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.6% 10/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.6% 12/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	21.9% 7/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Alkaline Phosphatase Increased	12.8% 23/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.0% 16/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	56.4% 22/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	35.3% 24/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	46.9% 15/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Blood and lymphatic system disorders Anemia	23.5% 42/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	42.2% 27/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	71.8% 28/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	54.4% 37/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	59.4% 19/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Anorexia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	13.2% 9/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	21.9% 7/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Anxiety	3.4% 6/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 4/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Aspartate Aminotransferase Increased	8.9% 16/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	18.8% 12/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	41.0% 16/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	22.1% 15/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	40.6% 13/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Back Pain	11.2% 20/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	39.1% 25/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	43.6% 17/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	33.8% 23/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	46.9% 15/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Blood Bilirubin Increased	3.9% 7/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 10/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 7/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	21.9% 7/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 5/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Bruising	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Cardiac disorders Cardiac disorders - other	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Cholesterol high	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Constipation	6.1% 11/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 6/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	30.8% 12/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	16.2% 11/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	37.5% 12/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	23.1% 9/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	13.2% 9/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 5/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Creatinine Increased	5.0% 9/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 8/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	19.1% 13/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 4/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Depression	4.5% 8/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	11.8% 8/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Diarrhea	4.5% 8/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.0% 16/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	46.2% 18/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.6% 12/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	37.5% 12/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Dizziness	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 8/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 5/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Dry Mouth	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 4/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Dysesthesia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Dysgeusia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 10/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	30.8% 12/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	34.4% 11/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Dyspepsia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.9% 7/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Dysphagia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.1% 11/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 10/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	35.9% 14/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	26.5% 18/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	21.9% 7/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Edema Face	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Edema Limbs	7.3% 13/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.9% 7/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	38.5% 15/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	27.9% 19/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 5/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Eye disorders Eye disorders - other	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Fatigue	16.2% 29/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	40.6% 26/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	74.4% 29/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	55.9% 38/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	65.6% 21/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Fever	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 4/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 4/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Gastrointestinal disorders - other	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.8% 5/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Headache	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.8% 5/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	11.8% 8/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	21.9% 7/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Hematuria	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 5/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Hemoglobinuria	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Vascular disorders Hot Flashes	10.6% 19/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	29.7% 19/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	30.8% 12/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	29.4% 20/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	43.8% 14/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hyperglycemia	8.4% 15/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 10/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	30.8% 12/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	14.7% 10/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	21.9% 7/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.9% 7/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Vascular disorders Hypertension	10.1% 18/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.2% 11/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	43.6% 17/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	26.5% 18/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	46.9% 15/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.8% 5/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.9% 7/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.8% 5/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	13.2% 9/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypokalemia	8.4% 15/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.2% 11/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	46.2% 18/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	26.5% 18/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	31.2% 10/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypomagnesemia	5.6% 10/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	14.1% 9/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	33.3% 13/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	13.2% 9/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.0% 8/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hyponatremia	5.0% 9/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.4% 6/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Vascular disorders Hypotension	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Infections and infestations Infections and infestations - other	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Insomnia	6.1% 11/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.8% 5/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.4% 6/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Lymphocyte count decreased	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	18.8% 6/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Memory Impairment	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Mucositis Oral	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 6/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	23.1% 9/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	18.8% 6/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Nausea	8.9% 16/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.0% 16/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	51.3% 20/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	20.6% 14/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	34.4% 11/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 4/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Neutrophil Count Decreased	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	14.1% 9/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.6% 10/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Non-Cardiac Chest Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Oral Dysesthesia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Oral Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
General disorders Pain	17.9% 32/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	37.5% 24/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	66.7% 26/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	42.6% 29/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	53.1% 17/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.8% 5/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrom	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Paresthesia	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 4/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	4.7% 3/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 4/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	9.4% 3/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Platelet Count Decreased	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 10/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.9% 7/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	18.8% 6/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 4/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Proteinuria	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.8% 5/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.8% 5/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.9% 4/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	15.6% 5/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Skin and subcutaneous tissue disorders Skin Hipopigmentation	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.8% 5/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	20.5% 8/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Stomach Pain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Vascular disorders Thromboembolic Event	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.7% 3/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 4/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Urinary Frequency	10.6% 19/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	17.2% 11/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	28.2% 11/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	23.5% 16/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	28.1% 9/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Urinary Incontinence	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	12.5% 8/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Renal and urinary disorders Urinary Retention	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	5.1% 2/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Infections and infestations Urinary Tract Infection	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	10.3% 7/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Gastrointestinal disorders Vomiting	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 4/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	25.6% 10/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	8.8% 6/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Weight Gain	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.8% 5/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations Weight Loss	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	0.00% 0/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	6.2% 2/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.
Investigations White Blood Cell Decreased	0.00% 0/179 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	23.4% 15/64 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	28.2% 11/39 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	7.4% 5/68 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.	31.2% 10/32 • Monitored continuously from baseline/first dose until 30 days post last dose, an average of 1 year •Death • A Life-threatening adverse drug experience-it does not include an adverse experience that might have caused death •Inpatient hospitalization or prolongation of existing hospitalization •A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions •A congenital anomaly/birth defect. The AEs are identified based on the arms the subjects were in. Each column is titled to show what study drug the subject was on when the AE occurred.

Additional Information

Paul Corn, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 563-7208

Email: pcorn@mdanderson.org

Results disclosure agreements

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