A Study Evaluating S 95005 Plus Bevacizumab and Capecitab... | NCT02743221

ID	Type	Description	Link
2015-004544-18	EudraCT Number

Name	Class
ADIR, a Servier Group company	INDUSTRY

Label	Type	Description	Intervention Names
Trifluridine/tipiracil + bevacizumab	Experimental	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks.	Drug: Trifluridine/tipiracil + bevacizumab
Capecitabine + bevacizumab	Active Comparator	Capecitabine was administered at 1250 mg/m² orally BID (bis in die)on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks	Drug: Capecitabine + bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
Trifluridine/tipiracil + bevacizumab	Drug	Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	Trifluridine/tipiracil + bevacizumab

Measure	Description	Time Frame
Progression Free Survival (PFS)	The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.	Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Measure	Description	Time Frame
Overall Response Rate (ORR)	As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.	Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

Name	Affiliation	Role
Eric Van Custem, Prof	Leuven Cancer Institute, University Hospitals Leuven	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Chris O'Brien Lifehouse Oncology		Camperdown		NSW 2050	Australia
Austin Hospital Olivia Newton-John Cancer & Wellness Centre

PubMed Identifier	Type	Citation	Retractions
35440667	Background	Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Fougeray R, Egorov A, Amellal N, Moiseyenko V. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Br J Cancer. 2022 Jun;126(11):1548-1554. doi: 10.1038/s41416-022-01737-2. Epub 2022 Apr 19.
32497736

ID	Type	URL	Comment
	Individual Participant Data Set	View IPD

ID	Title	Description
FG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 25, 2017	Jan 15, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.

Full Analysis Set (FAS): all randomised patients who have taken at least one dose of study treatment.

Posted

Median

95% Confidence Interval

months

Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

ID	Title	Description
OG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
OG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Units	Counts
Participants	OG00077 OG00176

Title

Denominators

Categories

Title	Measurements
	OG0009.2(7.6 to 11.6) OG0017.8(5.5 to 10.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cox proportional hazard model	Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)	0.09		Hazard Ratio (HR)	0.71			2-Sided	95	0.48	1.06					Other	This was a non-comparative study.

Secondary

Overall Response Rate (ORR)

As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.

FAS

Posted

Count of Participants

Participants

Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

ID	Title	Description
OG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
OG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Secondary

Duration of Response (DR)

The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.

Tumour Response population: patients with measurable disease at baseline and with at least one tumour evaluation while on treatment.

Posted

Median

80% Confidence Interval

months

Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)

ID	Title	Description
OG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
OG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Secondary

Disease Control Rate (DCR)

DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.

FAS

Posted

Count of Participants

Participants

Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)

ID	Title	Description
OG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
OG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Secondary

Overall Survival (OS)

The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.

FAS

Posted

Median

80% Confidence Interval

months

Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)

ID	Title	Description
OG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
OG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected77 at risk EG0010 events0 affected76 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0013 events3 affected76 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected77 at risk EG0010 events0 affected76 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0015 events5 affected76 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Gastrointestinal angiodysplasia haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0011 events1 affected76 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Malignant bowel obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected77 at risk EG0011 events1 affected76 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Mucosal dryness	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Abdominal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Biliary sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Catheter site infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Device related sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0011 events1 affected76 at risk
Pneumonia toxoplasmal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Blood calcium decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood magnesium decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood phosphorus decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood potassium decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Troponin T increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
White blood cell count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0015 events5 affected76 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected77 at risk EG00116 events16 affected76 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Aphasia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Memory impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected77 at risk EG0012 events2 affected76 at risk
Depressed mood	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected77 at risk EG0012 events2 affected76 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0014 events3 affected76 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0014 events4 affected76 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0010 events0 affected76 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0012 events2 affected76 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00031 events22 affected77 at risk EG0017 events5 affected76 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected77 at risk EG0012 events1 affected76 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events6 affected77 at risk EG0015 events2 affected76 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG000181 events40 affected77 at risk EG0015 events5 affected76 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00022 events11 affected77 at risk EG0015 events4 affected76 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events4 affected77 at risk EG0010 events0 affected76 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Aortic valve thickening	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Dry eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0010 events0 affected76 at risk
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Eye pruritus	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Lacrimation increased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0015 events4 affected76 at risk
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0012 events2 affected76 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00018 events9 affected77 at risk EG0017 events6 affected76 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected77 at risk EG0013 events2 affected76 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0011 events1 affected76 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00021 events13 affected77 at risk EG00117 events15 affected76 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00091 events40 affected77 at risk EG00164 events31 affected76 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0017 events6 affected76 at risk
Dyschezia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected77 at risk EG0012 events2 affected76 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Eructation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected77 at risk EG0011 events1 affected76 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected77 at risk EG0011 events1 affected76 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Lip dry	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Lip pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00084 events36 affected77 at risk EG00123 events13 affected76 at risk
Oral mucosa erosion	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Oral pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected77 at risk EG0013 events3 affected76 at risk
Proctitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Rectal discharge	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00018 events13 affected77 at risk EG00129 events16 affected76 at risk
Stomatitis haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00044 events22 affected77 at risk EG0018 events8 affected76 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG00019 events14 affected77 at risk EG00122 events17 affected76 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0013 events3 affected76 at risk
Discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Early satiety	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00045 events28 affected77 at risk EG00135 events23 affected76 at risk
Feeling hot	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Impaired healing	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0013 events3 affected76 at risk
Injection site haematoma	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Local swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0010 events0 affected76 at risk
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected77 at risk EG0013 events3 affected76 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Puncture site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected77 at risk EG0015 events4 affected76 at risk
Tenderness	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Xerosis	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0017 events5 affected76 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0013 events3 affected76 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Furuncle	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Gingivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hepatic cyst infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Labyrinthitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0011 events1 affected76 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0014 events3 affected76 at risk
Oral fungal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0014 events4 affected76 at risk
Oral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Periumbilical abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected77 at risk EG0011 events1 affected76 at risk
Skin candida	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Tooth abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected77 at risk EG0012 events2 affected76 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected77 at risk EG0016 events5 affected76 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0013 events2 affected76 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected77 at risk EG0015 events5 affected76 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Abdominal wall wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0015 events2 affected76 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected77 at risk EG0016 events4 affected76 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Stoma site irritation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Stoma site pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00011 events9 affected77 at risk EG0012 events2 affected76 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected77 at risk EG0012 events2 affected76 at risk
Bilirubin conjugated increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0011 events1 affected76 at risk
Blood albumin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0012 events2 affected76 at risk
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00018 events6 affected77 at risk EG00113 events8 affected76 at risk
Blood bilirubin unconjugated increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood cholesterol increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0005 events3 affected77 at risk EG0011 events1 affected76 at risk
Blood glucose increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Blood lactate dehydrogenase decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0005 events1 affected77 at risk EG0015 events4 affected76 at risk
Blood phosphorus increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Blood potassium decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood potassium increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected77 at risk EG0010 events0 affected76 at risk
Blood urea increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Blood urine present	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Carcinoembryonic antigen increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Eosinophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected77 at risk EG0013 events2 affected76 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Heart rate irregular	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
International normalised ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0012 events2 affected76 at risk
Lymphocyte count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0007 events4 affected77 at risk EG0012 events1 affected76 at risk
Monocyte count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00090 events18 affected77 at risk EG0011 events1 affected76 at risk
Neutrophil count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00022 events7 affected77 at risk EG0015 events3 affected76 at risk
Platelet count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected77 at risk EG0010 events0 affected76 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00012 events9 affected77 at risk EG0017 events6 affected76 at risk
Weight increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
White blood cell count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00037 events15 affected77 at risk EG0011 events1 affected76 at risk
White blood cell count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00046 events29 affected77 at risk EG00123 events15 affected76 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0010 events0 affected76 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected77 at risk EG0012 events2 affected76 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected77 at risk EG0010 events0 affected76 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected77 at risk EG0012 events2 affected76 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected77 at risk EG0011 events1 affected76 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0011 events1 affected76 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected77 at risk EG0010 events0 affected76 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0008 events6 affected77 at risk EG0013 events3 affected76 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected77 at risk EG0017 events7 affected76 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0011 events1 affected76 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0015 events4 affected76 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0011 events1 affected76 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected77 at risk EG0011 events1 affected76 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected77 at risk EG0013 events3 affected76 at risk
Amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Aphonia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Balance disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0007 events5 affected77 at risk EG00110 events8 affected76 at risk
Dizziness exertional	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Dizziness postural	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Dysarthria	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected77 at risk EG0018 events8 affected76 at risk
Essential tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00013 events7 affected77 at risk EG0014 events4 affected76 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events1 affected76 at risk
Memory impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected77 at risk EG0010 events0 affected76 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0013 events3 affected76 at risk
Neurotoxicity	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Orthostatic intolerance	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0012 events2 affected76 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0011 events1 affected76 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0013 events2 affected76 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0012 events1 affected76 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Disorientation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected77 at risk EG0011 events1 affected76 at risk
Mood altered	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Restlessness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Stress	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Anuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0013 events3 affected76 at risk
Glycosuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events1 affected76 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0012 events2 affected76 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Nocturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Proteinuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected77 at risk EG0015 events4 affected76 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0016 events6 affected76 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected77 at risk EG0011 events1 affected76 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected77 at risk EG00111 events8 affected76 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected77 at risk EG0012 events2 affected76 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected77 at risk EG0016 events4 affected76 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0013 events3 affected76 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0013 events3 affected76 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected77 at risk EG0010 events0 affected76 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected77 at risk EG0014 events4 affected76 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected77 at risk EG00149 events39 affected76 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected77 at risk EG0011 events1 affected76 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0011 events1 affected76 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events1 affected76 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected76 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0012 events2 affected76 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected77 at risk EG0011 events1 affected76 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected77 at risk EG00112 events10 affected76 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected77 at risk EG0011 events1 affected76 at risk

ID	Term
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis
D009369	Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013936	Thymidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D003841	Deoxycytidine
D003562	Cytidine
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones

ID	Title	Description
BG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
BG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Trifluridine/Tipiracil + Bevacizumab	Trifluridine/tipiracil (S95005): film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride. Bevacizumab: concentrate for solution for IV infusion containing 25mg/ml of bevacizumab. Trifluridine/tipiracil was administered at 35 mg/m2/dose orally within 1 hour after completion of morning and evening meals, for 5 days on/2 days off, over 2 weeks, followed by a 14-day rest period, with bevacizumab administered intravenously at the dose of 5 mg/kg every 2 weeks at Day 1 and Day 15.This treatment cycle was repeated every 4 weeks. Trifluridine/tipiracil + bevacizumab: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.	22	77	42	77	75	77
EG001	Capecitabine + Bevacizumab	Capecitabine was administered at 1250 mg/m² orally BID on Days 1-14 of each cycle, with bevacizumab (7.5 mg/kg, IV) administered on Day 1 of each cycle. This treatment cycle was repeated every 3 weeks Capecitabine + bevacizumab: Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.	33	76	44	76	69	76

ID	Term
D014271	Trifluridine
C000613754	tipiracil
D000068258	Bevacizumab
D000069287	Capecitabine