Trial Outcomes & Findings for Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer (NCT NCT01395017)

NCT ID: NCT01395017

Last Updated: 2016-04-08

Results Overview

Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

202 participants

Primary outcome timeframe

From randomization until date of death from any cause by 02 December 2013

Results posted on

2016-04-08

Participant Flow

202 participants were enrolled at 79 study sites in 15 countries.

Participants were randomly assigned in a 1:1 ratio to receive dasatinib + gemcitabine (GEM) or placebo + GEM. Participants were stratified at the time of randomization by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (0 versus 1) and intent to receive radiotherapy (RT) (yes or no).

Participant milestones

Participant milestones
Measure	Dasatinib + GEM GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).	Placebo + GEM GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
Overall Study STARTED	100	102
Overall Study Treated	98	101
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	100	102

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib + GEM GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).	Placebo + GEM GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
Overall Study Lost to Follow-up	1	0
Overall Study Adverse Event	26	12
Overall Study Physician Decision	11	15
Overall Study Withdrawal by Subject	14	8
Overall Study Protocol deviation	1	2
Overall Study Death	4	3
Overall Study Disease progression	42	58
Overall Study Sponsor discontinued study	1	4

Baseline Characteristics

Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib + GEM n=100 Participants GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.	Placebo + GEM n=102 Participants GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.	Total n=202 Participants Total of all reporting groups
Age, Continuous	64.8 Years STANDARD_DEVIATION 9.1 • n=5 Participants	64.7 Years STANDARD_DEVIATION 9.6 • n=7 Participants	64.8 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	56 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	46 Participants n=7 Participants	103 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until date of death from any cause by 02 December 2013

Population: The intent-to-treat (ITT) data which was composed of all randomized participants.

Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.

Outcome measures

Outcome measures
Measure	Dasatinib + GEM n=100 Participants GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD	Placebo + GEM n=102 Participants GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
Overall Survival	375 Days Interval 310.0 to 450.0	393 Days Interval 356.0 to 467.0

SECONDARY outcome

Timeframe: Time from randomization to earliest PFS event by 02 December 2013

Population: The ITT data which was composed of all randomized participants.

PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.

Outcome measures

Outcome measures
Measure	Dasatinib + GEM n=100 Participants GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD	Placebo + GEM n=102 Participants GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
Progression Free Survival (PFS)	167 Days Interval 114.0 to 212.0	166 Days Interval 160.0 to 199.0

Adverse Events

Dasatinib + GEM

Serious events: 53 serious events

Other events: 93 other events

Deaths: 0 deaths

Placebo + GEM

Serious events: 48 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Affairs

Otsuka Pharmaceutical Development and Commercialization, Inc.

Phone: 800 562-3974

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Dasatinib + GEM n=98 participants at risk GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD	Placebo + GEM n=101 participants at risk GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
Blood and lymphatic system disorders Anemia	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Arrhythmia	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Atrial fibrillation	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Cardiac arrest	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Cardiac failure	4.1% 4/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	2.0% 2/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Cardiac failure acute	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Cardiac failure congestive	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Cardiomyopathy	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Cardiac disorders Sick sinus syndrome	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Abdominal pain	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Abdominal pain upper	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Ascites	2.0% 2/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	2.0% 2/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Constipation	2.0% 2/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Diarrhoea	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Metabolism and nutrition disorders Failure to thrive	2.0% 2/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Duodenitis	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Enteritis	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Intestinal obstruction	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Nausea	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Obstruction gastric	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Pancreatic necrosis	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Small intestine obstruction	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Vomiting	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	2.0% 2/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Asthenia	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Device occlusion	5.1% 5/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.0% 5/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders General physical health deterioration	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Generalised oedema	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Hyperthermia	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Multi-organ failure	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Oedema	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Oedema peripheral	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Pyrexia	1.0% 1/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	4.0% 4/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Stent malfunction	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Sudden death	0.00% 0/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Hepatobiliary disorders Bile duct obstruction	4.1% 4/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	2.0% 2/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Hepatobiliary disorders Bile duct stenosis	2.0% 2/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.00% 0/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.

Other adverse events
Measure	Dasatinib + GEM n=98 participants at risk GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD	Placebo + GEM n=101 participants at risk GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.5% 25/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	18.8% 19/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Blood and lymphatic system disorders Anemia	51.0% 50/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	27.7% 28/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Blood and lymphatic system disorders Leukopenia	8.2% 8/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	12.9% 13/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Blood and lymphatic system disorders Lymphopenia	5.1% 5/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	6.9% 7/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Blood and lymphatic system disorders Neutropenia	54.1% 53/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	48.5% 49/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Blood and lymphatic system disorders Thrombocytopenia	38.8% 38/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	38.6% 39/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Abdominal pain	33.7% 33/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	35.6% 36/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Abdominal pain upper	10.2% 10/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	17.8% 18/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Ascites	8.2% 8/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.9% 6/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Constipation	33.7% 33/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	27.7% 28/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Diarrhoea	41.8% 41/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	28.7% 29/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Dry mouth	5.1% 5/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.9% 6/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Dyspepsia	9.2% 9/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	6.9% 7/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Flatulence	6.1% 6/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	10.9% 11/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Nausea	66.3% 65/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	48.5% 49/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Stomatitis	9.2% 9/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	7.9% 8/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Gastrointestinal disorders Vomiting	40.8% 40/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	33.7% 34/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Asthenia	17.3% 17/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	15.8% 16/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Chest pain	2.0% 2/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	6.9% 7/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Chills	6.1% 6/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	4.0% 4/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Face oedema	5.1% 5/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Fatigue	51.0% 50/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	45.5% 46/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Oedema peripheral	32.7% 32/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	21.8% 22/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Pain	2.0% 2/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	7.9% 8/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
General disorders Pyrexia	22.4% 22/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	26.7% 27/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Hepatobiliary disorders Hyperbilirubinaemia	3.1% 3/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	6.9% 7/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Infections and infestations Nasopharyngitis	7.1% 7/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.0% 5/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Infections and infestations Oral candidiasis	7.1% 7/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.0% 5/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Infections and infestations Upper respiratory tract infection	7.1% 7/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	3.0% 3/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Infections and infestations Urinary tract infection	6.1% 6/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Alanine aminotransferase increased	22.4% 22/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	13.9% 14/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Aspartate aminotransferase increased	16.3% 16/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	10.9% 11/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Blood alkalne phosphatase increased	15.3% 15/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	7.9% 8/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Blood bilirubin increased	13.3% 13/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.9% 6/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Gamma glutamyltransferase increased	5.1% 5/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	0.99% 1/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Haemaglobin decreased	5.1% 5/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.9% 6/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Neutrophil count decreased	6.1% 6/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	5.0% 5/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Platelet count decreased	7.1% 7/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	4.0% 4/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations Weight decreased	21.4% 21/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	10.9% 11/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
Investigations White blood cell count decreased	8.2% 8/98 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.	2.0% 2/101 • Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable. The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.