Efficacy and Safety of Idelalisib (GS-1101) in Combinatio... | NCT01732926

NCT01732926

ID	Type	Description	Link
2012-004034-42	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rituximab + Bendamustine + Idelalisib	Experimental	Participants will receive rituximab + bendamustine + idelalisib.	Drug: Idelalisib Drug: Rituximab Drug: Bendamustine
Rituximab + Bendamustine + Placebo	Experimental	Participants will receive rituximab + bendamustine + placebo.	Drug: Rituximab Drug: Bendamustine Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Idelalisib	Drug	150 mg tablet administered orally twice daily	Rituximab + Bendamustine + Idelalisib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

Secondary Outcomes

Measure	Description	Time Frame
Complete Response Rate (CR)	Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
Overall Response Rate (ORR)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clearview Cancer Institute		Huntsville	Alabama	35805	United States
Ironwood Cancer and Research Center

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Idelalisib + Bendamustine + Rituximab	Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
FG001	Placebo + Bendamustine + Rituximab

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
BG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062± 10.5 BG00162± 11.1 BG00262± 10.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000132 BG00158 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG00026 BG0018 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00016 BG0018 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Russian Federation

Title	Measurements
	BG00016 BG00111 BG002

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)

PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Posted

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
OG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)

Units	Counts
Participants	OG0000 OG0010

Secondary

Complete Response Rate (CR)

Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Posted

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
OG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)

Units	Counts
Participants	OG000

Secondary

Overall Response Rate (ORR)

Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Posted

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
OG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)

Units	Counts
Participants

Secondary

Lymph Node Response Rate

Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Posted

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
OG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)

Units	Counts
Participants

Secondary

Overall Survival (OS)

Overall survival is defined as the interval from randomization to death from any cause.

Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.

Posted

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
OG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)			229	317	315	317
EG001	Placebo + Bendamustine + Rituximab	Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)			58	155	147	155

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected317 at risk EG0014 affected155 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00045 affected317 at risk EG0017 affected155 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected317 at risk EG0013 affected155 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0012 affected155 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Angina unstable	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Dilatation ventricular	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Right ventricular failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Ophthalmoplegia	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Colitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0009 affected317 at risk EG0010 affected155 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00014 affected317 at risk EG0012 affected155 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected317 at risk EG0011 affected155 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected317 at risk EG0011 affected155 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Death	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Device related thrombosis	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hypothermia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0012 affected155 at risk
Oedema	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG00067 affected317 at risk EG0012 affected155 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0011 affected155 at risk
Hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0010 affected155 at risk
Acute sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Anal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Arthritis infective	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Aspergillus infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Atypical pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Bronchiolitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Campylobacter infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Candida infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0005 affected317 at risk EG0011 affected155 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Conjunctivitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cytomegalovirus hepatitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0006 affected317 at risk EG0010 affected155 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Dengue fever	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Device related infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Empyema	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Encephalitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Enteritis infectious	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Erysipelas	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0012 affected155 at risk
Gingivitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Groin abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Haematoma infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Herpes simplex	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0011 affected155 at risk
Infected skin ulcer	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Infectious colitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Influenza	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0011 affected155 at risk
Listeria sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0005 affected317 at risk EG0013 affected155 at risk
Lower respiratory tract infection fungal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Lung infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0012 affected155 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Oral candidiasis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Otitis media chronic	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0009 affected317 at risk EG0010 affected155 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00024 affected317 at risk EG0014 affected155 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Pneumonia chlamydial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pneumonia fungal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0012 affected155 at risk
Salmonellosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0009 affected317 at risk EG0011 affected155 at risk
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0012 affected155 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Systemic mycosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0010 affected155 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0006 affected317 at risk EG0011 affected155 at risk
Urosepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Varicella	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0005 affected317 at risk EG0013 affected155 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Sacroiliac fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00014 affected317 at risk EG0010 affected155 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00012 affected317 at risk EG0010 affected155 at risk
Blood bilirubin increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0013 affected155 at risk
Transaminases increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Weight decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected317 at risk EG0011 affected155 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0010 affected155 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0011 affected155 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Richter's syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Balance disorder	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Complex regional pain syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Embolic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Facial paralysis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Lethargy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Mixed dementia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Presyncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Spinal cord compression	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Device dislocation	Product Issues	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Confusional state	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0011 affected155 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected317 at risk EG0012 affected155 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Renal impairment	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0011 affected155 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected317 at risk EG0010 affected155 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected317 at risk EG0010 affected155 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0006 affected317 at risk EG0010 affected155 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0010 affected155 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Generalised erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Pustular psoriasis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00018 affected317 at risk EG0010 affected155 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0010 affected155 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected317 at risk EG0010 affected155 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected317 at risk EG0010 affected155 at risk
Aortic stenosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected317 at risk EG0011 affected155 at risk
Embolism	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected317 at risk EG0011 affected155 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected317 at risk EG0010 affected155 at risk
Internal haemorrhage	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected317 at risk EG0011 affected155 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00051 affected317 at risk EG00118 affected155 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00018 affected317 at risk EG0017 affected155 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG000122 affected317 at risk EG00154 affected155 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00037 affected317 at risk EG00118 affected155 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected317 at risk EG00111 affected155 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00021 affected317 at risk EG00110 affected155 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00074 affected317 at risk EG00131 affected155 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000158 affected317 at risk EG00133 affected155 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected317 at risk EG0013 affected155 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00028 affected317 at risk EG0019 affected155 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00017 affected317 at risk EG0016 affected155 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected317 at risk EG0014 affected155 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000159 affected317 at risk EG00165 affected155 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00026 affected317 at risk EG0015 affected155 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG000100 affected317 at risk EG00125 affected155 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG00043 affected317 at risk EG00124 affected155 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected317 at risk EG00110 affected155 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG000103 affected317 at risk EG00151 affected155 at risk
Mucosal inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG00029 affected317 at risk EG0012 affected155 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG00038 affected317 at risk EG0017 affected155 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG000135 affected317 at risk EG00122 affected155 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00022 affected317 at risk EG00113 affected155 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00019 affected317 at risk EG0017 affected155 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00014 affected317 at risk EG0019 affected155 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00017 affected317 at risk EG00114 affected155 at risk
Oral candidiasis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00017 affected317 at risk EG0012 affected155 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00016 affected317 at risk EG0012 affected155 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00018 affected317 at risk EG00111 affected155 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00058 affected317 at risk EG00125 affected155 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00026 affected317 at risk EG0018 affected155 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG00038 affected317 at risk EG00116 affected155 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00065 affected317 at risk EG0013 affected155 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00051 affected317 at risk EG0014 affected155 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00012 affected317 at risk EG0019 affected155 at risk
Weight decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00041 affected317 at risk EG0016 affected155 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00065 affected317 at risk EG00125 affected155 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00052 affected317 at risk EG00111 affected155 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00019 affected317 at risk EG0012 affected155 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00022 affected317 at risk EG00112 affected155 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00023 affected317 at risk EG00112 affected155 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected317 at risk EG0018 affected155 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00021 affected317 at risk EG0016 affected155 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00011 affected317 at risk EG0018 affected155 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00023 affected317 at risk EG00110 affected155 at risk
Dysgeusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected317 at risk EG00110 affected155 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00045 affected317 at risk EG00118 affected155 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0008 affected317 at risk EG0019 affected155 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0009 affected317 at risk EG0019 affected155 at risk
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00040 affected317 at risk EG00116 affected155 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00071 affected317 at risk EG00137 affected155 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00040 affected317 at risk EG00111 affected155 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00025 affected317 at risk EG00110 affected155 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected317 at risk EG0015 affected155 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected317 at risk EG0014 affected155 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected317 at risk EG0016 affected155 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00054 affected317 at risk EG00122 affected155 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG000105 affected317 at risk EG00116 affected155 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00029 affected317 at risk EG0015 affected155 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected317 at risk EG0014 affected155 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected317 at risk EG0015 affected155 at risk

Certain Agreements

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D006402	Hematologic Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D054219	Neoplasms, Plasma Cell
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006474	Hemorrhagic Disorders
D016393	Lymphoma, B-Cell

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
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
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D008224	Lymphoma, Follicular
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008258	Waldenstrom Macroglobulinemia
D018442	Lymphoma, B-Cell, Marginal Zone

ID	Term
C552946	idelalisib
D000069283	Rituximab
D000069461	Bendamustine Hydrochloride