Efficacy and Safety of Idelalisib in Combination With Ofa... | NCT01659021

ID	Type	Description	Link
2012-001236-65	EudraCT Number

Label	Type	Description	Intervention Names
Idelalisib+ofatumumab	Experimental	Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.	Drug: Idelalisib Drug: Ofatumumab
Ofatumumab	Active Comparator	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.	Drug: Ofatumumab

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

Measure	Description	Time Frame
Progression-Free Survival	Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.	Randomization to End of Study (up to 60 months)

Measure	Description	Time Frame
Overall Response Rate	Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response. Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy. Partial response 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. Overall response rate was analyzed using KM estimates.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope		Duarte	California	91010	United States
California Cancer Associates for Research and Excellence (CCARE)

PubMed Identifier	Type	Citation
28257752	Result	Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.
	Result	Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.
	Result	Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.

ID	Title	Description
FG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 30, 2017	Jul 23, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival

Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.

Intent-to-Treat (ITT) Analysis Set included participants who were randomized in the study regardless of whether they received any study drug(s), or received a different regimen from that to which they were randomized. Treatment assignment was designated according to randomization.

Posted

Median

95% Confidence Interval

months

Randomization to End of Study (up to 60 months)

ID	Title	Description
OG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
OG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Units	Counts
Participants	OG000174 OG00187

Title

Denominators

Categories

Title	Measurements
	OG00016.6(13.7 to 19.6) OG0018.0(5.7 to 8.4)

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		Log Rank		<0.0001	P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).	Hazard Ratio (HR)	0.26			2-Sided	95	0.18	0.37			Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.		Superiority

Secondary

Overall Response Rate

Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
Partial response 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. Overall response rate was analyzed using KM estimates.

Participants in the ITT Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

percentage of participants

Randomization to End of Study (up to 60 months)

ID	Title	Description
OG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
OG001	Ofatumumab

Secondary

Lymph Node Response Rate

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

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

Posted

Number

95% Confidence Interval

percentage of participants

Randomization to End of Study (up to 60 months)

ID	Title	Description
OG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
OG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Secondary

Overall Survival

Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.

Participants in the ITT Analysis Set were analyzed.

Posted

Median

95% Confidence Interval

months

Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)

ID	Title	Description
OG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
OG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

Secondary

Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation

Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.

Participants in the ITT Analysis Set with chromosome 17p deletion and/or TP53 mutation were analyzed.

Posted

Median

95% Confidence Interval

months

Randomization to End of Study (up to 60 months)

ID	Title	Description
OG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Participants in this group had 17p deletion and/or TP53 mutation.
OG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Participants in this group had 17p deletion and/or TP53 mutation.

Secondary

Complete Response Rate

Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).

Participants in the ITT Analysis Set were analyzed.

Posted

Number

percentage of participants

Randomization to End of Study (up to 60 months)

ID	Title	Description
OG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
OG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected173 at risk EG0012 affected86 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00019 affected173 at risk EG0013 affected86 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected173 at risk EG0012 affected86 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected173 at risk EG0012 affected86 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Aortic valve disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0012 affected86 at risk
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Right ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
External ear inflammation	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected173 at risk EG0011 affected86 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected173 at risk EG0010 affected86 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected173 at risk EG0010 affected86 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0010 affected86 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0010 affected86 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0011 affected86 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Generalised oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Impaired self-care	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected173 at risk EG0011 affected86 at risk
Strangulated hernia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Anaphylactic shock	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Aspergillus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Atypical pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Bacterial sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Biliary sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 affected173 at risk EG0010 affected86 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Candida infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Candida pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Candida sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Chronic sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Escherichia sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Genital herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
H1N1 influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Listeria sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 affected173 at risk EG0012 affected86 at risk
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 affected173 at risk EG0010 affected86 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 affected173 at risk EG0012 affected86 at risk
Pneumocystis jirovecii infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0011 affected86 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 affected173 at risk EG0010 affected86 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00027 affected173 at risk EG0019 affected86 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0012 affected86 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pseudomonas infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0012 affected86 at risk
Respiratory tract infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Rhinovirus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Salmonellosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0011 affected86 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 affected173 at risk EG0011 affected86 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 affected173 at risk EG0010 affected86 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Varicella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Vascular device infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Viral sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0010 affected86 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
C-reactive protein increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Lymphocyte count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 affected173 at risk EG0010 affected86 at risk
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Troponin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0011 affected86 at risk
White blood cell count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected173 at risk EG0010 affected86 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0011 affected86 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0011 affected86 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected173 at risk EG0010 affected86 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Pseudohyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Central nervous system leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Malignant ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Aphasia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Embolic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Facial paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Hemiparesis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Hypotonia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Locked-in syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Device occlusion	Product Issues	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Mania	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Mental status changes	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected173 at risk EG0010 affected86 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected173 at risk EG0010 affected86 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected173 at risk EG0010 affected86 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected173 at risk EG0010 affected86 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected173 at risk EG0010 affected86 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected173 at risk EG0011 affected86 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected173 at risk EG0011 affected86 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected173 at risk EG0011 affected86 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected173 at risk EG0010 affected86 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00038 affected173 at risk EG0017 affected86 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00057 affected173 at risk EG00114 affected86 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00025 affected173 at risk EG0015 affected86 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected173 at risk EG0012 affected86 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00028 affected173 at risk EG0015 affected86 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected173 at risk EG0014 affected86 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected173 at risk EG0010 affected86 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00039 affected173 at risk EG00113 affected86 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00096 affected173 at risk EG00121 affected86 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected173 at risk EG0013 affected86 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected173 at risk EG0013 affected86 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00062 affected173 at risk EG00123 affected86 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected173 at risk EG0010 affected86 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00029 affected173 at risk EG00112 affected86 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG00027 affected173 at risk EG0019 affected86 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected173 at risk EG0012 affected86 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG00027 affected173 at risk EG00113 affected86 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00060 affected173 at risk EG00124 affected86 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected173 at risk EG0011 affected86 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected173 at risk EG0011 affected86 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG00035 affected173 at risk EG0019 affected86 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected173 at risk EG0012 affected86 at risk
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected173 at risk EG0011 affected86 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00055 affected173 at risk EG00119 affected86 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0013 affected86 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00025 affected173 at risk EG0010 affected86 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0012 affected86 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00015 affected173 at risk EG0010 affected86 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 affected173 at risk EG0012 affected86 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00021 affected173 at risk EG0012 affected86 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 affected173 at risk EG0011 affected86 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00023 affected173 at risk EG0013 affected86 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00047 affected173 at risk EG0019 affected86 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00018 affected173 at risk EG0016 affected86 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00018 affected173 at risk EG0013 affected86 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG00030 affected173 at risk EG00123 affected86 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00019 affected173 at risk EG0012 affected86 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00014 affected173 at risk EG0012 affected86 at risk
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00016 affected173 at risk EG0012 affected86 at risk
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0009 affected173 at risk EG0011 affected86 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00028 affected173 at risk EG0015 affected86 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00037 affected173 at risk EG0017 affected86 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected173 at risk EG0010 affected86 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected173 at risk EG0011 affected86 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00032 affected173 at risk EG0014 affected86 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0013 affected86 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected173 at risk EG0011 affected86 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00019 affected173 at risk EG0015 affected86 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00028 affected173 at risk EG00111 affected86 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00018 affected173 at risk EG0012 affected86 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected173 at risk EG0011 affected86 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected173 at risk EG0011 affected86 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00019 affected173 at risk EG0015 affected86 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0013 affected86 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected173 at risk EG0015 affected86 at risk
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0013 affected86 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00037 affected173 at risk EG0019 affected86 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected173 at risk EG0011 affected86 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0016 affected86 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0014 affected86 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected173 at risk EG0015 affected86 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected173 at risk EG0012 affected86 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected173 at risk EG0010 affected86 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00030 affected173 at risk EG00112 affected86 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00060 affected173 at risk EG00118 affected86 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected173 at risk EG0011 affected86 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00034 affected173 at risk EG00111 affected86 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected173 at risk EG0016 affected86 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0016 affected86 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected173 at risk EG0013 affected86 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected173 at risk EG0010 affected86 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected173 at risk EG0011 affected86 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected173 at risk EG0011 affected86 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected173 at risk EG00110 affected86 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00021 affected173 at risk EG0016 affected86 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00036 affected173 at risk EG0017 affected86 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected173 at risk EG0010 affected86 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00021 affected173 at risk EG0016 affected86 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected173 at risk EG0015 affected86 at risk

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
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

ID	Title	Description
BG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
BG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Idelalisib+Ofatumumab	Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.	87	174	136	173	167	173
EG001	Ofatumumab	Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.	40	87	36	86	79	86