Trial Outcomes & Findings for Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel (NCT NCT03419234)

NCT ID: NCT03419234

Last Updated: 2026-01-29

Results Overview

PFS is defined as time from randomization to radiographic progression, symptomatic deterioration requiring discontinuation of treatment or death, whichever occurs first. Patients who died without documented radiographic progression or symptomatic deterioration and the death occurred more than 6.5 months after the date of last disease assessment were censored at the date of last disease assessment.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

223 participants

Primary outcome timeframe

Assessed every 9 weeks for the first 18 weeks, then every 12 weeks until treatment discontinuation; if treatment discontinued prior to radiographic progression, then every 3 months until radiographic progression, up to 5 years

Results posted on

2026-01-29

Participant Flow

This study was activated on February 8, 2018 and closed to accrual on March 26, 2021, after accrual of 223 patients.

Participant milestones

Participant milestones
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.	Arm B (Abiraterone Acetate, Prednisone) Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.
Overall Study STARTED	111	112
Overall Study Patients who received protocol therapy	109	108
Overall Study Patients who started protocol therapy and had both baseline PSA as well as 12-week PSA available	100	93
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	111	112

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.	Arm B (Abiraterone Acetate, Prednisone) Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.
Overall Study Disease progression	37	36
Overall Study Adverse Event	6	9
Overall Study Withdrawal by Subject	9	7
Overall Study Death	5	1
Overall Study Alternative therapy	4	2
Overall Study PSA progression	8	10
Overall Study Rising PSA and bone issues	3	2
Overall Study Clinical deterioration/clinical progression/symptomatic progression	10	16
Overall Study Physician Decision	12	11
Overall Study Second malignancy	1	0
Overall Study Insurance status change/patient could not afford	2	1
Overall Study Non-compliance	1	3
Overall Study Mistakenly off treatment	1	0
Overall Study Transition to hospice	1	0
Overall Study Still on treatment	9	8
Overall Study Never received protocol therapy	2	4
Overall Study Other complicating disease	0	1
Overall Study patient switched from prednisone to another steroid	0	1

Baseline Characteristics

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=111 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.	Arm B (Abiraterone Acetate, Prednisone) n=112 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.	Total n=223 Participants Total of all reporting groups
Age, Continuous	63 years n=35 Participants	66 years n=4328 Participants	64 years n=8687 Participants
Sex: Female, Male Female	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Sex: Female, Male Male	111 Participants n=35 Participants	112 Participants n=4328 Participants	223 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=35 Participants	5 Participants n=4328 Participants	10 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=35 Participants	105 Participants n=4328 Participants	209 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants	2 Participants n=4328 Participants	4 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	2 Participants n=4328 Participants	2 Participants n=8687 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	2 Participants n=4328 Participants	2 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	20 Participants n=35 Participants	22 Participants n=4328 Participants	42 Participants n=8687 Participants
Race (NIH/OMB) White	84 Participants n=35 Participants	81 Participants n=4328 Participants	165 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=35 Participants	5 Participants n=4328 Participants	12 Participants n=8687 Participants

PRIMARY outcome

Timeframe: Assessed every 9 weeks for the first 18 weeks, then every 12 weeks until treatment discontinuation; if treatment discontinued prior to radiographic progression, then every 3 months until radiographic progression, up to 5 years

Population: All randomized patients are included in this analysis.

Outcome measures

Outcome measures
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=111 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Cabazitaxel: Given IV Prednisone: Given PO	Arm B (Abiraterone Acetate, Prednisone) n=112 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Prednisone: Given PO
Progression-free Survival (PFS)	14.9 months Interval 9.9 to 18.6	9.9 months Interval 7.0 to 12.6

SECONDARY outcome

Timeframe: Assessed at baseline and 12 weeks

Population: Patients who started protocol therapy and had both baseline PSA as well as 12-week PSA available are included in this analysis.

PSA was assessed at baseline and 12 weeks. Percent change in PSA from baseline to 12 weeks is calculated as follows: ((PSA at 12 weeks - baseline PSA)/baseline PSA) x 100

Outcome measures

Outcome measures
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=100 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Cabazitaxel: Given IV Prednisone: Given PO	Arm B (Abiraterone Acetate, Prednisone) n=93 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Prednisone: Given PO
Percent Change in PSA From Baseline to 12 Weeks	-87.5 percentage of change in PSA Interval -94.9 to -52.1	-65.9 percentage of change in PSA Interval -91.3 to -16.1

SECONDARY outcome

Timeframe: Assessed at baseline, every 3 weeks for 18 weeks, then every 6 weeks until treatment discontinuation, up to 5 years

Population: Patients who started protocol therapy are included in this analysis.

Maximum percent change in PSA from baseline while on treatment was calculated as follows: ((PSA nadir while on treatment - baseline PSA)/baseline PSA) x 100

Outcome measures

Outcome measures
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=109 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Cabazitaxel: Given IV Prednisone: Given PO	Arm B (Abiraterone Acetate, Prednisone) n=108 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Prednisone: Given PO
Maximum Percent Change in PSA From Baseline While on Treatment	-94.0 percentage of change in PSA Interval -98.1 to -65.8	-67.7 percentage of change in PSA Interval -94.8 to -15.5

SECONDARY outcome

Timeframe: Assessed at baseline, every 3 weeks for 18 weeks, then every 6 weeks until treatment discontinuation, up to 5 years

Population: All randomized patients are included in this analysis.

Time to PSA progression was defined as the time from randomization to PSA progression or date of last PSA assessment. Patients who experienced radiographic progression without documented PSA progression were counted as having an event.

Outcome measures

Outcome measures
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=111 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Cabazitaxel: Given IV Prednisone: Given PO	Arm B (Abiraterone Acetate, Prednisone) n=112 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Prednisone: Given PO
Time to PSA Progression	10.0 months Interval 8.5 to 13.5	6.1 months Interval 4.4 to 8.0

SECONDARY outcome

Population: All randomized patients are included in this analysis.

Radiographic response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and was defined as either complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. All (non-target) lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=111 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Cabazitaxel: Given IV Prednisone: Given PO	Arm B (Abiraterone Acetate, Prednisone) n=112 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Prednisone: Given PO
Proportion of Patients With Radiographic Response	0.117 Proportion of participants Interval 0.064 to 0.192	0.080 Proportion of participants Interval 0.037 to 0.147

SECONDARY outcome

Timeframe: Assessed every 3 month is patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, and then annually for up to year 5

Population: All randomized patients are included in this analysis.

Overall survival was defined as the time from randomization until death or date last known alive.

Outcome measures

Outcome measures
Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=111 Participants Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Cabazitaxel: Given IV Prednisone: Given PO	Arm B (Abiraterone Acetate, Prednisone) n=112 Participants Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy. Abiraterone Acetate: Given PO Androgen deprivation therapy: Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist or surgical castration with bilateral orchiectomy. Prednisone: Given PO
Overall Survival (OS)	25.0 months Interval 20.6 to 32.5	26.9 months Interval 19.6 to 29.4

Outcome data not reported

Adverse Events

Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel)

Serious events: 46 serious events

Other events: 101 other events

Deaths: 80 deaths

Arm B (Abiraterone Acetate, Prednisone)

Serious events: 31 serious events

Other events: 80 other events

Deaths: 79 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) n=109 participants at risk Patients receive abiraterone acetate PO QD on days 1-21, prednisone PO BID on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel IV over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.	Arm B (Abiraterone Acetate, Prednisone) n=108 participants at risk Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.
Blood and lymphatic system disorders Anemia	55.0% 60/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	27.8% 30/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
General disorders and administration site conditions Edema limbs	20.2% 22/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	12.0% 13/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
General disorders and administration site conditions Fatigue	71.6% 78/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	43.5% 47/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Gastrointestinal disorders Constipation	11.0% 12/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	7.4% 8/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Gastrointestinal disorders Diarrhea	33.9% 37/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	5.6% 6/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Gastrointestinal disorders Nausea	5.5% 6/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	1.9% 2/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Gastrointestinal disorders Vomiting	16.5% 18/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	3.7% 4/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Infections and infestations Urinary tract infection	6.4% 7/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	1.9% 2/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Investigations Lymphocyte count decreased	12.8% 14/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	2.8% 3/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Investigations Neutrophil count decreased	7.3% 8/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	0.93% 1/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Investigations White blood cell decreased	6.4% 7/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	0.93% 1/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Metabolism and nutrition disorders Anorexia	6.4% 7/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	0.93% 1/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Metabolism and nutrition disorders Hypokalemia	17.4% 19/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	17.6% 19/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 6/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	0.93% 1/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.0% 12/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	8.3% 9/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.
Vascular disorders Hypertension	33.9% 37/109 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.	33.3% 36/108 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years All randomized patients are included in the analysis of all-cause mortality. Only patients who received protocol therapy are included in the analysis of adverse events.