Trial Outcomes & Findings for Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC (NCT NCT01995058)

NCT ID: NCT01995058

Last Updated: 2026-01-08

Results Overview

PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, as assessed by Independent Radiology Committee (IRC). The sponsor terminated the study early due to business reasons. As such, no data were collected for efficacy analyses.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Up to 18 Months

Results posted on

2026-01-08

Participant Flow

This study enrolled subjects from 11 February 2014 (first patient enrolled) through 02 September 2014 (Sponsor decision to end study). The study was terminated prior to completing enrollment due to Sponsor decision (not based on any safety results).

Participant milestones

Participant milestones
Measure	Arm 1 - Cabozantinib 40 mg, po QD + Abiraterone Cabozantinib 40 mg, po QD + abiraterone with prednisone	Arm 2 - Cabozantinib 20 mg, po QD + Abiraterone Cabozantinib 20 mg, po QD + abiraterone with prednisone	Arm 3 - Cabozantinib 20 mg, po QOD + Abiraterone Cabozantinib 20 mg, po QOD + abiraterone with prednisone	Arm 4 - Abiraterone Only Abiraterone with prednisone
Overall Study STARTED	14	13	13	14
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	14	13	13	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 - Cabozantinib 40 mg, po QD + Abiraterone Cabozantinib 40 mg, po QD + abiraterone with prednisone	Arm 2 - Cabozantinib 20 mg, po QD + Abiraterone Cabozantinib 20 mg, po QD + abiraterone with prednisone	Arm 3 - Cabozantinib 20 mg, po QOD + Abiraterone Cabozantinib 20 mg, po QOD + abiraterone with prednisone	Arm 4 - Abiraterone Only Abiraterone with prednisone
Overall Study Sponsor Decision to terminate study	14	12	12	10
Overall Study Progressive Disease	0	1	1	1
Overall Study Adverse Event	0	0	0	1
Overall Study Lack of Efficacy	0	0	0	1
Overall Study No Treatment Given	0	0	0	1

Baseline Characteristics

Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 - Cabozantinib 40 mg, po QD + Abiraterone n=14 Participants Cabozantinib 40 mg, po QD + abiraterone with prednisone	Arm 2 - Cabozantinib 20 mg, po QD + Abiraterone n=13 Participants Cabozantinib 20 mg, po QD + abiraterone with prednisone	Arm 3 - Cabozantinib 20 mg, po QOD + Abiraterone n=13 Participants Cabozantinib 20 mg, po QOD + abiraterone with prednisone	Arm 4 - Abiraterone Only n=14 Participants Abiraterone with prednisone only	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=18 Participants	2 Participants n=17 Participants	3 Participants n=35 Participants	3 Participants n=42 Participants	10 Participants n=217 Participants
Age, Categorical >=65 years	12 Participants n=18 Participants	11 Participants n=17 Participants	10 Participants n=35 Participants	11 Participants n=42 Participants	44 Participants n=217 Participants
Age, Continuous	76 years n=18 Participants	74 years n=17 Participants	73 years n=35 Participants	70 years n=42 Participants	73 years n=217 Participants
Sex: Female, Male Female	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Sex: Female, Male Male	14 Participants n=18 Participants	13 Participants n=17 Participants	13 Participants n=35 Participants	14 Participants n=42 Participants	54 Participants n=217 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=18 Participants	12 Participants n=17 Participants	13 Participants n=35 Participants	14 Participants n=42 Participants	52 Participants n=217 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants	1 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	2 Participants n=217 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	3 Participants n=17 Participants	3 Participants n=35 Participants	2 Participants n=42 Participants	8 Participants n=217 Participants
Race (NIH/OMB) White	13 Participants n=18 Participants	10 Participants n=17 Participants	10 Participants n=35 Participants	12 Participants n=42 Participants	45 Participants n=217 Participants
Race (NIH/OMB) More than one race	1 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	1 Participants n=217 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants	0 Participants n=217 Participants
Region of Enrollment United States	14 participants n=18 Participants	13 participants n=17 Participants	13 participants n=35 Participants	14 participants n=42 Participants	54 participants n=217 Participants

PRIMARY outcome

Timeframe: Up to 18 Months

Population: As pre-specified in the protocol, a total of 140 PFS events were required for this analysis; given that only 54 participants were enrolled and the study terminated early after 9 months, no data were collected or analyzed as planned for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Arm 2

Serious events: 4 serious events

Other events: 10 other events

Deaths: 1 deaths

Arm 3

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm 4

Serious events: 1 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Exelixis Medical Information

Exelixis, Inc.

Phone: 855-292-3935

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreements with investigators vary; constant is our right to review results communications prior to public release, and embargo communications for a period of ≤60 days from submittal for review. We do not prohibit investigators from publishing, but we may require previously undisclosed confidential information, other than study results, to be removed from publications, and single-center publications are postponed until after publication of the trial's primary multicenter publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Arm 1 n=14 participants at risk Cabozantinib 40 mg, po QD + abiraterone with prednisone	Arm 2 n=14 participants at risk Cabozantinib 20 mg, po QD + abiraterone with prednisone	Arm 3 n=12 participants at risk Cabozantinib 20 mg, po QOD + abiraterone with prednisone	Arm 4 n=13 participants at risk Abiraterone with prednisone
Blood and lymphatic system disorders Anemia	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Renal and urinary disorders Renal failure acute	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Renal and urinary disorders Uncoded: left sided obstructive uropathy	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Cardiac disorders Myocardial infarction	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Infections and infestations Bronchitis	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Chest pain	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Ileus	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Mucositis	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Injury, poisoning and procedural complications Subdural hematoma	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Uncoded: swelling to left tongue	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Infections and infestations Pneumonia	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Infections and infestations Septic shock	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.

Other adverse events
Measure	Arm 1 n=14 participants at risk Cabozantinib 40 mg, po QD + abiraterone with prednisone	Arm 2 n=14 participants at risk Cabozantinib 20 mg, po QD + abiraterone with prednisone	Arm 3 n=12 participants at risk Cabozantinib 20 mg, po QOD + abiraterone with prednisone	Arm 4 n=13 participants at risk Abiraterone with prednisone
Vascular disorders Hypertension	21.4% 3/14 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	21.4% 3/14 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	25.0% 3/12 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	15.4% 2/13 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Investigations Lipase increased	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Blood and lymphatic system disorders Anaemia	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	15.4% 2/13 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Skin and subcutaneous tissue disorders Blister	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Investigations Blood phosphorus decreased	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Chest pain	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	15.4% 2/13 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Metabolism and nutrition disorders Hypokalaemia	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Metabolism and nutrition disorders Hyponatraemia	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Mucosal inflammation	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Renal and urinary disorders Ureteric obstruction	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	23.1% 3/13 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Investigations Blood alkaline phosphatase increased	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	23.1% 3/13 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Blood and lymphatic system disorders Thrombocytopenia	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Endocrine disorders Hypothyroidism	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Eye disorders Lacrimation increased	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Eye disorders Photophobia	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	15.4% 2/13 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Nausea	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Constipation	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	15.4% 2/13 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Dyspepsia	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	16.7% 2/12 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Flatulence	14.3% 2/14 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Abdominal distension	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	8.3% 1/12 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Lip pain	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Odynophagia	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Oedema mouth	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Oral pain	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Stomatitis	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	7.7% 1/13 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Fatigue	28.6% 4/14 • Number of events 4 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	21.4% 3/14 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	16.7% 2/12 • Number of events 2 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	23.1% 3/13 • Number of events 3 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Feeling abnormal	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Medical device complication	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.
General disorders Non-cardiac chest pain	7.1% 1/14 • Number of events 1 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/14 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/12 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.	0.00% 0/13 • Up to 7 months One subject was randomized to the 20 mg QOD combination arm but received 20 mg cabozantinib treatment on a QD schedule according to the clinical database dosing records. In the Safety population, this subject was included in the 20 QD combination arm and not in the 20 QOD combination arm. Another subject was randomized to the abiraterone only arm, but never received study treatment.