A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combinatio... | NCT01647828

Label	Type	Description	Intervention Names
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel	Experimental	OMP-59R5 plus Gemcitabine and Nab-Paclitaxel	Drug: OMP-59R5 Drug: Gemcitabine Drug: Nab-Paclitaxel
Gemcitabine and Nab-Paclitaxel plus Placebo	Experimental	Gemcitabine and Nab-Paclitaxel plus Placebo	Drug: Gemcitabine Drug: Placebo Drug: Nab-Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
OMP-59R5	Drug	OMP-59R5 administered intravenously	OMP-59R5 plus Gemcitabine and Nab-Paclitaxel

Measure	Description	Time Frame
Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)	Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).	Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Overall Survival (ITT Population)	To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.	Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Median OS by Notch 3 Percentile (ITT Population)	To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.	Up to 1 year in absence of unacceptable toxicity or disease progression.

Name	Affiliation	Role
Eileen M O'Reilly, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Western Regional Medical Center, Inc.		Goodyear	Arizona	85338	United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

PubMed Identifier	Type	Citation	Retractions
31347292	Derived	Hu ZI, Bendell JC, Bullock A, LoConte NK, Hatoum H, Ritch P, Hool H, Leach JW, Sanchez J, Sohal DPS, Strickler J, Patel R, Wang-Gillam A, Firdaus I, Yu KH, Kapoun AM, Holmgren E, Zhou L, Dupont J, Picozzi V, Sahai V, O'Reilly EM. A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer. Cancer Med. 2019 Sep;8(11):5148-5157. doi: 10.1002/cam4.2425. Epub 2019 Jul 26.

ID	Title	Description
FG000	P1B: OMP-59R5 2.5 mg/kg + Gem	Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
FG001	P1B: OMP-59R5 5 mg/kg + Gem

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG0031 affected6 at risk EG004
Constipation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cellulitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Enterobacter bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Groin Abscess	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Herpes zoster	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peritonitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sepsis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Fatigue	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Death	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pyrexia	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Presyncope	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombotic stroke	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood bilirubin increased	Investigations	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Asthenia	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Catheter site pain	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oedema	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oedema peripheral	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pain	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Embolism	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematoma	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypertension	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lipase increased	Investigations	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA version 15.1	Non-systematic Assessment	EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0003 affected5 at risk EG0012 affected4 at risk EG0024 affected4 at risk EG0035 affected6 at risk EG004
Anemia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0004 affected5 at risk EG0012 affected4 at risk EG0022 affected4 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Diarrhoea	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0003 affected5 at risk EG0011 affected4 at risk EG0024 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastrooesphageal reflux disease	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Anorectal discomfort	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dental Caries	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment	"Gastrointestinal disorder" is a single adverse event system organ class/preferred term used under the Gastrointestinal disorders	EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pancreatic insufficiency	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rectal fissure	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Fatigue	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Oedema Peripheral	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0024 affected4 at risk EG003
Pyrexia	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0023 affected4 at risk EG003
Asthenia	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Chills	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Mucosal inflammation	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Early satiety	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Gait disturbance	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Influenza like illness	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Catheter site erythema	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Catheter site pruritus	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Chest Pain	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Face oedema	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Instillation site erythema	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Localised oedema	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Medical device complication	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Pain	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0011 affected4 at risk EG0021 affected4 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pruritus generalized	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin discoloration	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Headache	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Ageusia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Presyncope	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Syncope	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombotic stroke	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tremor	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0022 affected4 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hot flush	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0011 affected4 at risk EG0021 affected4 at risk EG003
Embolism	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Hypertension	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Weight decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
White blood cell count decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood bilirubin increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0002 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
International normalised ratio increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0012 affected4 at risk EG0020 affected4 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0011 affected4 at risk EG0020 affected4 at risk EG003
Blood creatinine increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiac murmur	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Candidiasis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cellulitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Folliculitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hordeolum	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Liver abscess	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Mucosal infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rhinitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Sepsis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sinusitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Pubic pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Subdermal haematoma	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Depression	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Anxiety	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Insomnia	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Confusional state	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Intracardiac thrombus	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Palpitations	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tachycardia	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0001 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Priapism	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Scrotal cyst	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Eye pruritus	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0021 affected4 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Retching	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Abdominal rigidity	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Faeces soft	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pneumoperitoneum	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sensitivity of teeth	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tongue discolouration	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tongue disorder	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tooth disorder	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oedema	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Malaise	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infusion site pain	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Chest discomfort	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infusion site discomfort	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peripheral swelling	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Systemic inflammatory response syndrome	Gastrointestinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Catheter site haemorrhage	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Catheter site pain	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Device occlusion	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Infusion site irritation	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Injection site reaction	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Splenic infarction	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Splenic vein thrombosis	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lethargy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Memory impairment	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Neuralgia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Somnolence	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Amnesia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Balance disorder	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Burning sensation	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hemianopia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyporeflexia	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Migraine	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Motor dysfunction	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nystagmus	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peroneal nerve palsy	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sciatica	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sedation	Nervous system disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nail pigmentation	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cystitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Candida infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Device related infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Furuncle	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Herpes zoster	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pharyngitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Catheter site infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Diverticulitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Enterobacter bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Groin abscess	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Localised infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oral herpes	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oral infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Otitis externa	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Paronychia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Parotitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peritonitis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peritonitis bacterial	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Rash pustular	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tooth infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Wound infection	Infections and infestations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood glucose increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood albumin decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood creatinine decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood fibrinogen decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood parathyroid hormone decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Blood phosphorus increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Computerised tomogram thorax abnormal	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Eosinophil count decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematocrit decreased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lipase increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Liver function test abnormal	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lymphocyte count increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Neutrophil count increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
White blood cell count increased	Investigations	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Flushing	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Haematoma	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Phlebitis	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombosis	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Embolism venous	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lymphoedema	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Orthostatic hypertension	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Restlessness	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Agitation	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Irritability	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Irritability	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Somnambulism	Psychiatric disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Urinary tract pain	Renal and urinary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bradycardia	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholangitis sclerosing	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Gallbladder perforation	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skeletal injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Skin abrasion	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Vision blurred	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Dry eye	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ocular icterus	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Cataract	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Eye irritation	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Eye pain	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Visual impairment	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Xanthopsia	Eye disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Middle ear inflammation	Ear and labyrinth disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Ovarian vein thrombosis	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA version 15.1	Non-systematic Assessment		EG0000 affected5 at risk EG0010 affected4 at risk EG0020 affected4 at risk EG003

ID	Title	Description
BG000	P1B: OMP-59R5 2.5 mg/kg + Gem	Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG001	P1B: OMP-59R5 5 mg/kg + Gem	Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG002	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem	Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG003	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem	Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG004	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem	Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG005	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem	Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG006	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem	Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG007	P2: Placebo + Nab-P + Gem	Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG008	P2: OMP-59R5 15 mg/kg + Nab-P + Gem	Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).
BG009	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	P1B: OMP-59R5 2.5 mg/kg + Gem	Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	3	5	4	5	5	5
EG001	P1B: OMP-59R5 5 mg/kg + Gem	Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	4	4	1	4	4	4
EG002	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem	Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	4	4	1	4	4	4
EG003	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem	Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	5	6	3	6	6	6
EG004	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem	Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	6	6	4	6	6	6
EG005	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem	Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	3	3	1	3	3	3
EG006	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem	Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	10	12	9	12	12	12
EG007	P2: Placebo + Nab-P + Gem	Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	60	88	51	85	85	85
EG008	P2: OMP-59R5 15 mg/kg + Nab-P + Gem	Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).	71	89	58	87	87	87

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
C000606143	tarextumab
D000093542	Gemcitabine
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins