Trial Outcomes & Findings for OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone (NCT NCT01681433)

Last Updated: 2022-07-11

Results Overview

To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

60 days

Results posted on

2022-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Arm A OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Overall Study STARTED	36	36
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	32	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Arm A OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Overall Study Lack of Efficacy	23	23
Overall Study Withdrawal by Subject	5	5
Overall Study Protocol Violation	2	0
Overall Study Adverse Event	2	4
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Arm A n=36 Participants OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=36 Participants Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Total n=72 Participants Total of all reporting groups
Age, Continuous	71 years n=93 Participants	72 years n=4 Participants	72 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	36 Participants n=4 Participants	72 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	28 Participants n=4 Participants	58 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment Canada	14 participants n=93 Participants	15 participants n=4 Participants	29 participants n=27 Participants
Region of Enrollment United States	22 participants n=93 Participants	21 participants n=4 Participants	43 participants n=27 Participants
ECOG Status ECOG 0	16 participants n=93 Participants	16 participants n=4 Participants	32 participants n=27 Participants
ECOG Status ECOG 1	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants
Median PSA	34.19 ug/L n=93 Participants	18.17 ug/L n=4 Participants	23 ug/L n=27 Participants

PRIMARY outcome

Timeframe: 60 days

To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.

Outcome measures

Outcome measures
Measure	Experimental: Arm A n=36 Participants OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=36 Participants Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Progression-Free Survival	12 participants	6 participants

SECONDARY outcome

Timeframe: 60 days

Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.

Outcome measures

Outcome measures
Measure	Experimental: Arm A n=36 Participants OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=36 Participants Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
PSA Response PSA DECLINE >= 30%	2 participants	2 participants
PSA Response PSA DELCINE >=50 %	2 participants	1 participants
PSA Response ANY DECLINE	13 participants	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 days

Compare arms to determine the objective response of study patients, per RECIST 1.1

Outcome measures

Outcome measures
Measure	Experimental: Arm A n=33 Participants OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=30 Participants Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Objective Response Partial Response	1 participants	0 participants
Objective Response Stable Disease	6 participants	5 participants
Objective Response Progressive Disease	26 participants	25 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 days

Compare arms to determine the time to disease progression of study patients

Outcome measures

Outcome measures
Measure	Experimental: Arm A n=36 Participants OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=36 Participants Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Time to Disease Progression	1.9055 months Interval 1.0842 to 2.32341	1.0842 months Interval 0.9856 to 1.8398

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 4 weeks

Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study

Outcome measures

Outcome measures
Measure	Experimental: Arm A n=32 Participants OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=30 Participants Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Circulating Tumor Cell (CTC) Counts Best CTC Change from Baseline >=5 to <5	8 participants	4 participants
Circulating Tumor Cell (CTC) Counts Best CTC Change from Baseline <5 to <5	16 participants	15 participants
Circulating Tumor Cell (CTC) Counts Best CTC Change from Baseline >=5 to >=5	7 participants	10 participants
Circulating Tumor Cell (CTC) Counts Best CTC Change from Baseline<5 to >=5	1 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 4 weeks

Population: Data for this secondary objective was not collected or analyzed

Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 4 weeks

Population: Data for this objective was not collected or analyzed

Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Arm A

Serious events: 12 serious events

Other events: 51 other events

Deaths: 8 deaths

Control Arm: Arm B

Serious events: 6 serious events

Other events: 32 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Data Coordinator

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental: Arm A n=56 participants at risk OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily	Control Arm: Arm B n=36 participants at risk Continuation of standard therapy with abiraterone acetate and prednisone Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily Prednisone: Standard therapy: Prednisone 10-20 mg PO daily
Renal and urinary disorders ACUTE KIDNEY INJURY	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Psychiatric disorders CONFUSION	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Gastrointestinal disorders CONSTIPATION	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Renal and urinary disorders CYSTITIS NONINFECTIVE	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Metabolism and nutrition disorders DEHYDRATION	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	5.6% 2/36 • Number of events 2 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Respiratory, thoracic and mediastinal disorders DYSPNEA	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
General disorders EDEMA LIMBS	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Injury, poisoning and procedural complications FRACTURE	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Renal and urinary disorders HEMATURIA	3.6% 2/56 • Number of events 2 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Infections and infestations INFECTIONS AND INFESTATIONS	5.4% 3/56 • Number of events 3 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Gastrointestinal disorders NAUSEA	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
General disorders PAIN	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Renal and urinary disorders RENAL AND URINARY DISORDERS	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Renal and urinary disorders URINARY RETENTION	3.6% 2/56 • Number of events 2 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Infections and infestations URINARY TRACT INFECTION	1.8% 1/56 • Number of events 3 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Renal and urinary disorders URINARY TRACT OBSTRUCTION	1.8% 1/56 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	0.00% 0/36 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Blood and lymphatic system disorders ANEMIA	0.00% 0/56 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 2 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/56 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS	0.00% 0/56 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Nervous system disorders NERVOUS SYSTEM DISORDERS	0.00% 0/56 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/56 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.	2.8% 1/36 • Number of events 1 • Every four weeks, up to 48 weeks or disease progression. All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.