Trial Outcomes & Findings for A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab (NCT NCT03368859)

Last Updated: 2021-02-09

Results Overview

PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively

Results posted on

2021-02-09

Participant Flow

The intent to treat (ITT) population included all randomized participants and was used for all efficacy and baseline analyses.

A total of 70 participants were randomized to 1 of the 2 study treatments. Participants were grouped according to treatment as randomized.

Participant milestones

Participant milestones
Measure	ABT-165 Plus FOLFIRI ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Overall Study STARTED	36	34
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	36	34

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-165 Plus FOLFIRI ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Overall Study Withdrew Consent	5	4
Overall Study Death	12	6
Overall Study Study terminated by Sponsor	18	23
Overall Study Other	1	1

Baseline Characteristics

A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-165 Plus FOLFIRI n=36 Participants ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI n=34 Participants Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Total n=70 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 11.41 • n=93 Participants	60.2 years STANDARD_DEVIATION 10.19 • n=4 Participants	60.5 years STANDARD_DEVIATION 10.76 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	19 Participants n=4 Participants	40 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=93 Participants	31 Participants n=4 Participants	65 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Asian	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Missing	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively

Population: Intent to Treat (ITT): includes all randomized participants.

PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.

Outcome measures

Outcome measures
Measure	ABT-165 Plus FOLFIRI n=36 Participants ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI n=34 Participants Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Progression Free Survival (PFS)	3.78 Months Interval 2.07 to 7.2	7.36 Months Interval 5.68 to 10.55

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively

Population: ITT

ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

Outcome measures

Outcome measures
Measure	ABT-165 Plus FOLFIRI n=36 Participants ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI n=34 Participants Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Objective Response Rate (ORR)	5.6 percentage of participants Interval 0.7 to 18.7	14.7 percentage of participants Interval 5.0 to 31.1

SECONDARY outcome

Population: ITT

OS is defined as the time from randomization until death from any cause.

Outcome measures

Outcome measures
Measure	ABT-165 Plus FOLFIRI n=36 Participants ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI n=34 Participants Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Overall Survival (OS)	7.95 Months Interval 7.0 to Due to early termination of the study, there was insufficient follow-up time, which limited estimates of OS.	NA Months Interval 10.55 to Due to early termination of the study, there was insufficient follow-up time, which limited estimates of OS.

Adverse Events

ABT-165 Plus FOLFIRI

Serious events: 17 serious events

Other events: 32 other events

Deaths: 12 deaths

Bevacizumab Plus FOLFIRI

Serious events: 8 serious events

Other events: 31 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	ABT-165 Plus FOLFIRI n=34 participants at risk ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity	Bevacizumab Plus FOLFIRI n=32 participants at risk Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil) IV infusion for a 14 day cycle until disease progression or intolerable toxicity
Blood and lymphatic system disorders ANAEMIA	2.9% 1/34 • Number of events 2 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	5.9% 2/34 • Number of events 2 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Blood and lymphatic system disorders NEUTROPENIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Cardiac disorders ATRIAL FIBRILLATION	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders ABDOMINAL PAIN	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders ANAL HAEMORRHAGE	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders GASTRIC PERFORATION	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders GASTROINTESTINAL PERFORATION	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders ILEUS	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Gastrointestinal disorders INTESTINAL PERFORATION	5.9% 2/34 • Number of events 2 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
General disorders ASTHENIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
General disorders DISEASE PROGRESSION	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
General disorders PYREXIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Hepatobiliary disorders BILE DUCT STENOSIS	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Infections and infestations ANAL ABSCESS	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Infections and infestations CELLULITIS	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Infections and infestations HEPATITIS B	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Infections and infestations PNEUMONIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Infections and infestations SEPSIS	5.9% 2/34 • Number of events 2 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Infections and infestations SEPTIC SHOCK	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Metabolism and nutrition disorders DECREASED APPETITE	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Metabolism and nutrition disorders HYPERCALCAEMIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Metabolism and nutrition disorders HYPOKALAEMIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	8.8% 3/34 • Number of events 3 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	6.2% 2/32 • Number of events 2 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Nervous system disorders ENCEPHALOPATHY	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/34 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	3.1% 1/32 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.
Vascular disorders DEEP VEIN THROMBOSIS	2.9% 1/34 • Number of events 1 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.	0.00% 0/32 • Adverse events were collected from first dose of study drug to 90 days (+15 days) after the last dose and then every 90 days (+15 days) throughout the survival period;the median duration across both treatment groups was 38.6 (3.0-99.3) weeks.