Study Evaluating the Efficacy and Safety of Idelalisib in... | NCT01569295

NCT01569295

ID	Type	Description	Link
2011-006292-20	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
Idelalisib+bendamustine+rituximab	Experimental	Participants will receive idelalisib plus bendamustine and rituximab	Drug: Idelalisib Drug: Rituximab Drug: Bendamustine
Placebo to match idelalisib+bendamustine+rituximab	Placebo Comparator	Participants will receive placebo to match idelalisib plus bendamustine and rituximab	Drug: Rituximab Drug: Bendamustine Drug: Placebo to match idelalisib

Name	Type	Description	Arm Group Labels	Other Names
Idelalisib	Drug	Idelalisib 150 mg administered orally twice daily	Idelalisib+bendamustine+rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.	Up to 84 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy. PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.

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
UCLA Medical Center

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.
	Background	Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.
	Background	Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.
	Background	Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA
28139405

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 21, 2017	Feb 19, 2020

Arm/Group Information

ID	Title	Description
BG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
BG001	Placebo + Bendamustine + Rituximab	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 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± 9.2 BG00163± 9.8 BG00262± 9.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00047 BG00153 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
White	BG000187 BG001190 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Hispanic or Latino	BG0004 BG0015 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Romania

Title	Measurements
	BG0005 BG0016 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 was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.

The intent-to-treat (ITT) Analysis Set included all participants randomised in the study regardless of whether study drug was administered and with treatment group designated according to initial randomisation.

Posted

Median

95% Confidence Interval

months

Up to 84 months

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
OG001	Placebo + Bendamustine + Rituximab	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).

Units	Counts
Participants	OG000207 OG001209

Title

Denominators

Categories

Title	Measurements
	OG00021.8(16.5 to 27.8) OG00111.1(8.9 to 11.1)

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		Stratified log-rank test		< 0.0001		Hazard Ratio (HR)	0.35			2-Sided	95	0.27	0.45			Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.		Superiority

Secondary

Overall Response Rate (ORR)

ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.

PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.

Participants in the ITT Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 84 months

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
OG001	Placebo + Bendamustine + Rituximab

Secondary

Lymph Node Response Rate

Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.

Participants in the ITT Analysis Set with available data were analyzed.

Posted

Number

95% Confidence Interval

percentage of particpants

Up to 84 months

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
OG001	Placebo + Bendamustine + Rituximab	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).

Secondary

Overall Survival

Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.

Participants in the ITT Analysis Set were analyzed.

Posted

Median

95% Confidence Interval

months

Up to 84 months

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
OG001	Placebo + Bendamustine + Rituximab	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).

Secondary

Complete Response Rate

Complete response (CR) rate was defined as the percentage of participants who achieved a CR.

Participants in the ITT Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Up to 84 months

ID	Title	Description
OG000	Idelalisib + Bendamustine + Rituximab	Idelalisib 150 mg tablet administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).
OG001	Placebo + Bendamustine + Rituximab	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).

Units

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 administered orally twice daily (until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation) + rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/mg^2/infusion on days 1 and 2 of each 28 day cycle, administered intravenously for a total of 6 cycles (12 infusions).	89	207	152	207	199	207
EG001	Placebo + Bendamustine + Rituximab	Placebo to match idelalisib administered orally twice daily + rituximab 375 mg/m^2 on Day 1, then 500 mg/ m^2 every 28 days administered intravenously for a total of 6 infusions + bendamustine 70 mg/m^2/infusion on days 1 and 2 of each 28 day cycle administered intravenously for a total of 6 cycles (12 infusions).	106	209	94	209	196	209

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0008 affected207 at risk EG0015 affected209 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG00045 affected207 at risk EG00110 affected209 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0009 affected207 at risk EG0013 affected209 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0010 affected209 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Angina pectoris	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Cardiac arrest	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Cardiac failure	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Pericardial effusion	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Vision blurred	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0012 affected209 at risk
Ascites	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Colitis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0005 affected207 at risk EG0011 affected209 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Constipation	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00014 affected207 at risk EG0011 affected209 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Nausea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0012 affected209 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Asthenia	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0012 affected209 at risk
Chest pain	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Chills	General disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Fatigue	General disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0012 affected209 at risk
General physical health deterioration	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Malaise	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Pyrexia	General disorders	MedDRA (22.0)	Systematic Assessment	EG00025 affected207 at risk EG00111 affected209 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Hypersensitivity	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Aspergillus infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Bacteraemia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Bacterial sepsis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Brain abscess	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Bronchitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0015 affected209 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cellulitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0010 affected209 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cystitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cytomegalovirus enteritis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0011 affected209 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Device related infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0011 affected209 at risk
Diverticulitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Ecthyma	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Escherichia sepsis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Eye infection toxoplasmal	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Fungal infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Gastroenteritis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
H1n1 influenza	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Haemophilus infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Herpes simplex	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Herpes zoster	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0011 affected209 at risk
Human herpesvirus 6 infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Impetigo	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Influenza	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0011 affected209 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0007 affected207 at risk EG0015 affected209 at risk
Lower respiratory tract infection fungal	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Lung infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0013 affected209 at risk
Meningitis aseptic	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Meningitis bacterial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Meningitis enteroviral	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Neutropenic infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0016 affected209 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Oral herpes	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Oropharyngitis fungal	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Otitis externa	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Otitis media	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Perineal infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Pharyngeal abscess	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0010 affected209 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00038 affected207 at risk EG00116 affected209 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Pneumonia viral	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pulmonary mycosis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pulmonary sepsis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0005 affected207 at risk EG0015 affected209 at risk
Rhinovirus infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Sepsis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00011 affected207 at risk EG0014 affected209 at risk
Septic shock	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0005 affected207 at risk EG0011 affected209 at risk
Sinusitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Skin infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Soft tissue infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Tonsillitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Tuberculosis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0014 affected209 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0007 affected207 at risk EG0013 affected209 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Urosepsis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0011 affected209 at risk
Viral infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0013 affected209 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Alanine aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Bk polyomavirus test positive	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Blood creatinine increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Neutrophil count decreased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Streptococcus test positive	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Transaminases increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0012 affected209 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Chondritis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Reiter's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0012 affected209 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0010 affected209 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0010 affected209 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0015 affected209 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0012 affected209 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Dizziness	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Headache	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Seizure	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Syncope	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Anxiety	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Confusional state	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Delusion	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Mental status changes	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Mood swings	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Panic attack	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Personality change	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0011 affected209 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Haematuria	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Renal colic	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Renal failure	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Perineal necrosis	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0012 affected209 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0013 affected209 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0003 affected207 at risk EG0010 affected209 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0004 affected207 at risk EG0010 affected209 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0015 affected209 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected207 at risk EG0011 affected209 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0010 affected209 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected207 at risk EG0010 affected209 at risk
Hypotension	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected207 at risk EG0012 affected209 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG00054 affected207 at risk EG00148 affected209 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG00017 affected207 at risk EG00110 affected209 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG000129 affected207 at risk EG001113 affected209 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG00041 affected207 at risk EG00146 affected209 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00021 affected207 at risk EG00113 affected209 at risk
Constipation	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00032 affected207 at risk EG00135 affected209 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00089 affected207 at risk EG00147 affected209 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00015 affected207 at risk EG0018 affected209 at risk
Nausea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00060 affected207 at risk EG00172 affected209 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00035 affected207 at risk EG00131 affected209 at risk
Asthenia	General disorders	MedDRA (22.0)	Systematic Assessment	EG00024 affected207 at risk EG00120 affected209 at risk
Chills	General disorders	MedDRA (22.0)	Systematic Assessment	EG00022 affected207 at risk EG00113 affected209 at risk
Fatigue	General disorders	MedDRA (22.0)	Systematic Assessment	EG00045 affected207 at risk EG00152 affected209 at risk
Oedema peripheral	General disorders	MedDRA (22.0)	Systematic Assessment	EG00017 affected207 at risk EG00118 affected209 at risk
Pyrexia	General disorders	MedDRA (22.0)	Systematic Assessment	EG00078 affected207 at risk EG00155 affected209 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG00012 affected207 at risk EG00110 affected209 at risk
Bronchitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00020 affected207 at risk EG0018 affected209 at risk
Herpes zoster	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00011 affected207 at risk EG0016 affected209 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00013 affected207 at risk EG00110 affected209 at risk
Nasopharyngitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00016 affected207 at risk EG00111 affected209 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00025 affected207 at risk EG00113 affected209 at risk
Respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0007 affected207 at risk EG00111 affected209 at risk
Sinusitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00019 affected207 at risk EG00113 affected209 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG00037 affected207 at risk EG00121 affected209 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG00029 affected207 at risk EG00145 affected209 at risk
Alanine aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG00032 affected207 at risk EG0012 affected209 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG00019 affected207 at risk EG0012 affected209 at risk
Weight decreased	Investigations	MedDRA (22.0)	Systematic Assessment	EG00025 affected207 at risk EG00112 affected209 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG00024 affected207 at risk EG00115 affected209 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG00021 affected207 at risk EG00116 affected209 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG00027 affected207 at risk EG00116 affected209 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG00017 affected207 at risk EG00115 affected209 at risk
Headache	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG00020 affected207 at risk EG00121 affected209 at risk
Anxiety	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0006 affected207 at risk EG00112 affected209 at risk
Insomnia	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG00019 affected207 at risk EG00113 affected209 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG00052 affected207 at risk EG00147 affected209 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG00020 affected207 at risk EG00126 affected209 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG00010 affected207 at risk EG00114 affected209 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG00017 affected207 at risk EG00112 affected209 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG00018 affected207 at risk EG0018 affected209 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG00017 affected207 at risk EG00112 affected209 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG00036 affected207 at risk EG00128 affected209 at risk
Hypertension	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG00013 affected207 at risk EG0015 affected209 at risk
Hypotension	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG00014 affected207 at risk EG00113 affected209 at risk

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D007938	Leukemia

ID	Term
C552946	idelalisib
D000069283	Rituximab
D000069461	Bendamustine Hydrochloride