Dasatinib Added to Gemcitabine for Subjects With Locally-... | NCT01395017

Label	Type	Description	Intervention Names
Group 1	Active Comparator	One arm will receive standard of care treatment (ie, 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).	Drug: dasatinib
Group 2	Placebo Comparator	The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
dasatinib	Drug	GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Measure	Description	Time Frame
Overall Survival	Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.	From randomization until date of death from any cause by 02 December 2013

Measure	Description	Time Frame
Progression Free Survival (PFS)	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.	Time from randomization to earliest PFS event by 02 December 2013

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35249	United States

ID	Title	Description
FG000	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).
FG001	Placebo + GEM	GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0011 affected101 at risk
Arrhythmia	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Cardiac arrest	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Cardiac failure	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0004 affected98 at risk EG0012 affected101 at risk
Cardiac failure acute	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Cardiomyopathy	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0011 affected101 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0011 affected101 at risk
Ascites	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0012 affected101 at risk
Constipation	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0010 affected101 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0010 affected101 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0010 affected101 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Duodenitis	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Enteritis	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0011 affected101 at risk
Nausea	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0011 affected101 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Small intestine obstruction	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0012 affected101 at risk
Asthenia	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Device occlusion	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0015 affected101 at risk
General physical health deterioration	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Generalised oedema	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Hyperthermia	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Multi-organ failure	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Oedema	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Oedema peripheral	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0010 affected101 at risk
Pyrexia	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0014 affected101 at risk
Stent malfunction	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Sudden death	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0004 affected98 at risk EG0012 affected101 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0010 affected101 at risk
Cholangitis	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0004 affected98 at risk EG0012 affected101 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0012 affected101 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0011 affected101 at risk
Jaundice	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0010 affected101 at risk
Abdominal abscess	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Abscess	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Bacteraemia	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Biliary sepsis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Biliary tract infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0010 affected101 at risk
Bronchitis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Cellulitis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0010 affected101 at risk
Device related infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Escherichia infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Escherichia sepsis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Liver abcess	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0011 affected101 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Lung infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Peritonitis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Pneumonia	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0011 affected101 at risk
Sepsis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0011 affected101 at risk
Streptococcal infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Urinary tract infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0010 affected101 at risk
Viral infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0011 affected101 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Chemical peritonitis	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Hepatic enzyme increased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Liver function test abnormal	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Platelet count decreased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0011 affected101 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0010 affected101 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0012 affected101 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0011 affected101 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Confusional state	Psychiatric disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Depression	Psychiatric disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Renal failure	Renal and urinary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Renal failure acute	Renal and urinary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0011 affected101 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0011 affected101 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0012 affected101 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Necrolytic migratory erythema	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Hypertension	Vascular disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Hypotension	Vascular disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk
Thrombosis	Vascular disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected101 at risk
Venous thrombosis	Vascular disorders	MedDRA version 16.0	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected101 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA version 16.0	Non-systematic Assessment	EG00050 affected98 at risk EG00128 affected101 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version 16.0	Non-systematic Assessment	EG0008 affected98 at risk EG00113 affected101 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0017 affected101 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 16.0	Non-systematic Assessment	EG00053 affected98 at risk EG00149 affected101 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 16.0	Non-systematic Assessment	EG00038 affected98 at risk EG00139 affected101 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00033 affected98 at risk EG00136 affected101 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00010 affected98 at risk EG00118 affected101 at risk
Ascites	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0008 affected98 at risk EG0016 affected101 at risk
Constipation	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00033 affected98 at risk EG00128 affected101 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00041 affected98 at risk EG00129 affected101 at risk
Dry mouth	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0016 affected101 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0009 affected98 at risk EG0017 affected101 at risk
Flatulence	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG00111 affected101 at risk
Nausea	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00065 affected98 at risk EG00149 affected101 at risk
Stomatitis	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG0009 affected98 at risk EG0018 affected101 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00040 affected98 at risk EG00134 affected101 at risk
Asthenia	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG00017 affected98 at risk EG00116 affected101 at risk
Chest pain	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0017 affected101 at risk
Chills	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0014 affected101 at risk
Face oedema	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0011 affected101 at risk
Fatigue	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG00050 affected98 at risk EG00146 affected101 at risk
Oedema peripheral	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG00032 affected98 at risk EG00122 affected101 at risk
Pain	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG0002 affected98 at risk EG0018 affected101 at risk
Pyrexia	General disorders	MedDRA version 16.0	Non-systematic Assessment	EG00022 affected98 at risk EG00127 affected101 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0017 affected101 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0007 affected98 at risk EG0015 affected101 at risk
Oral candidiasis	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0007 affected98 at risk EG0015 affected101 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0007 affected98 at risk EG0013 affected101 at risk
Urinary tract infection	Infections and infestations	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0011 affected101 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG00022 affected98 at risk EG00114 affected101 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG00016 affected98 at risk EG00111 affected101 at risk
Blood alkalne phosphatase increased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG00015 affected98 at risk EG0018 affected101 at risk
Blood bilirubin increased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG00013 affected98 at risk EG0016 affected101 at risk
Gamma glutamyltransferase increased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0011 affected101 at risk
Haemaglobin decreased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0016 affected101 at risk
Neutrophil count decreased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0015 affected101 at risk
Platelet count decreased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0007 affected98 at risk EG0014 affected101 at risk
Weight decreased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG00021 affected98 at risk EG00111 affected101 at risk
White blood cell count decreased	Investigations	MedDRA version 16.0	Non-systematic Assessment	EG0008 affected98 at risk EG0012 affected101 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG00048 affected98 at risk EG00123 affected101 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG0009 affected98 at risk EG0016 affected101 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 16.0	Non-systematic Assessment	EG00012 affected98 at risk EG00110 affected101 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0003 affected98 at risk EG0016 affected101 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0008 affected98 at risk EG00116 affected101 at risk
Muscloskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0001 affected98 at risk EG0016 affected101 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG00010 affected98 at risk EG0015 affected101 at risk
Dizziness	Nervous system disorders	MedDRA version 16.0	Non-systematic Assessment	EG0004 affected98 at risk EG00111 affected101 at risk
Dysgeusia	Nervous system disorders	MedDRA version 16.0	Non-systematic Assessment	EG00012 affected98 at risk EG0016 affected101 at risk
Headache	Nervous system disorders	MedDRA version 16.0	Non-systematic Assessment	EG00012 affected98 at risk EG0019 affected101 at risk
Anxiety	Psychiatric disorders	MedDRA version 16.0	Non-systematic Assessment	EG00010 affected98 at risk EG0014 affected101 at risk
Depression	Psychiatric disorders	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0015 affected101 at risk
Insomnia	Psychiatric disorders	MedDRA version 16.0	Non-systematic Assessment	EG00012 affected98 at risk EG00114 affected101 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00014 affected98 at risk EG00113 affected101 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00025 affected98 at risk EG00119 affected101 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 16.0	Non-systematic Assessment	EG00020 affected98 at risk EG0015 affected101 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG00010 affected98 at risk EG0017 affected101 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0013 affected101 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0005 affected98 at risk EG0013 affected101 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0012 affected101 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG0006 affected98 at risk EG0019 affected101 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 16.0	Non-systematic Assessment	EG00020 affected98 at risk EG00114 affected101 at risk
Hypertension	Vascular disorders	MedDRA version 16.0	Non-systematic Assessment	EG0004 affected98 at risk EG00110 affected101 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011743	Pyrimidines

ID	Title	Description
BG000	Dasatinib + GEM	GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
BG001	Placebo + GEM	GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dasatinib + GEM	GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD			53	98	93	98
EG001	Placebo + GEM	GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.			48	101	98	101