An Extension Study for Subjects Who Are Deriving Benefit... | NCT01090414

Label	Type	Description	Intervention Names
Idelalisib	Experimental	Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity.	Drug: Idelalisib

Name	Type	Description	Arm Group Labels	Other Names
Idelalisib	Drug	Idelalisib tablets or capsules administered orally	Idelalisib

Measure	Description	Time Frame
Overall Response Rate	Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).	Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events		Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days

Measure	Description	Time Frame
Duration of Response	Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.	Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

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

PubMed Identifier	Type	Citation	Retractions
	Result	Barrientos J, Coutre SE, et al. (2014). Long-Term Follow-Up of a Phase 1 Trial of Idelalisib (ZYDELIG®) in Combination with Bendamustine, Bendamustine/Rituximab, Fludarabine, Chlorambucil, or Chlorambucil/Rituximab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) [Abstract 3343]. 56th American Society of Hematology (ASH) Annual Meeting and Exposition, San Francisco, California.
	Result	Barrientos JC, Leonard JP, et al. (2013). Update on a Phase 1 Study of the Selective PI3Kδ Inhibitor, Idelalisib (GS-1101) in Combination with Rituximab and/or Bendamustine in Patients with Relapsed or Refractory CLL [Presentation]. American Society for Clinical Oncology (ASCO) Annual Meeting, Chicago, Illinois.
	Result	Barrientos JC, Wagner-Johnston ND, et al. (2013). Chemo-Immunotherapy Combination of Idelalisib with Bendamustine/Rituximab or Chlorambucil/Rituximab in Patients with Relapsed/ Refractory CLL Demonstrates Efficacy and Tolerability [Poster 4176]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.
	Result	Barrientos JC, Sharman J, et al. (2012). GS-1101 (CAL-101), A Selective Phosphatidylinositol 3-Kinase-Delta Inhibitor, in Combination With Ofatumumab for the Treatment of Relapsed/ Refractory CLL [Abstract 1062]. Haematologica: the Hematology Journal 17th Congress of the European Hematology Association 14-17 June 2012 Amsterdam; Netherlands 97 (Suppl 1): 433.
	Result	Benson D, Kahl BS, et al. (2013). Final Results of a Phase 1 Study of Idelalisib, a Selective Inhibitor of PI3Kδ, in Patients with Relapsed or Refractory Indolent non-Hodgkin Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

ID	Title	Description
FG000	101-02	Participants with chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma (iNHL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), or multiple myeloma (MM) received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Original	Jan 22, 2010	Apr 30, 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

Overall Response Rate

Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).

Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Posted

Number

95% Confidence Interval

percentage of participants

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

ID	Title	Description
OG000	101-02 (AML)	Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG001	101-02 (CLL)	Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG002	101-02 (DLBCL)	Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG003	101-02 (iNHL)	Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG004	101-02 (MCL)	Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG005	101-02 (MM)	Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG006	101-07 (CLL)	Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG007	101-07 (iNHL)	Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG008	101-07 (MCL)	Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG009	101-08 (CLL or SLL)	Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG010	101-10 (iNHL)	Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.

Units	Counts
Participants	OG00012 OG00154 OG0029 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 0) OG00157.4(43.2 to 70.8) OG00211.1(0.3 to 48.2) OG003

Primary

Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events

Data presented includes data from both the parent studies and this Study 101-99. For this safety endpoint, data was prespecified to be combined.

Posted

Number

percentage of participants

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days

ID	Title	Description
OG000	101-02	Participants with CLL or iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and entered long-term safety extension study 101-99 to receive the same treatment.
OG001	101-07	Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and entered long-term safety extension study 101-99 to receive the same treatment.
OG002	101-08	Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and entered long-term safety extension study 101-99 to receive the same treatment.

Secondary

Duration of Response

Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.

Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Posted

Median

95% Confidence Interval

Months

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

ID	Title	Description
OG000	101-02 (AML)	Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG001	101-02 (CLL)	Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG002	101-02 (DLBCL)

Secondary

Progression-Free Survival

Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates.

Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Posted

Median

95% Confidence Interval

Months

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

ID	Title	Description
OG000	101-02 (AML)	Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG001	101-02 (CLL)	Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG002	101-02 (DLBCL)

Secondary

Overall Survival

Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates.

Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Posted

Median

95% Confidence Interval

Months

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

ID	Title	Description
OG000	101-02 (AML)	Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG001	101-02 (CLL)	Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG002	101-02 (DLBCL)	Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.

Secondary

Time to Response

Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response.

Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants.

Posted

Median

Inter-Quartile Range

Months

Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

ID	Title	Description
OG000	101-02 (AML)	Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG001	101-02 (CLL)	Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
OG002	101-02 (DLBCL)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0015 affected241 at risk EG0021 affected64 at risk EG0030 affected18 at risk
Aplasia pure red cell	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Autoimmune neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Coombs positive haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected191 at risk EG00123 affected241 at risk EG0023 affected64 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0014 affected241 at risk EG0021 affected64 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0016 affected241 at risk EG0020 affected64 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Pulseless electrical activity	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Endocrine disorder	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Retinal detachment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Uveitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG00114 affected241 at risk EG00213 affected64 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Colitis microscopic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 affected191 at risk EG00114 affected241 at risk EG00213 affected64 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Generalised oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Impaired healing	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG00131 affected241 at risk EG0023 affected64 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Abdominal wall infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Abscess neck	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Aspergillus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Candida infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG0014 affected241 at risk EG0022 affected64 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Cerebral aspergillosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Corynebacterium bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cytomegalovirus gastrointestinal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Encephalitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Gangrene	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Groin abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Herpes zoster disseminated	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Herpes zoster pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Histoplasmosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Human herpesvirus 6 infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Hydrocele male infected	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Listeria sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Listeriosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Meningitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Meningitis aseptic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Meningitis enterococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Mycobacterium avium complex infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Neutropenic infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Pneumococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Pneumocystis jirovecii infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0018 affected241 at risk EG0021 affected64 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00030 affected191 at risk EG00140 affected241 at risk EG00212 affected64 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Pneumonia pseudomonal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG00114 affected241 at risk EG0021 affected64 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Sinusitis fungal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Systemic candida	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Tooth infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0013 affected241 at risk EG0023 affected64 at risk EG003
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Vulvovaginitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Blood uric acid increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
International normalised ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Liver function test increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0022 affected64 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0022 affected64 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Richter's syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Lethargy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected191 at risk EG0019 affected241 at risk EG0021 affected64 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Acute lung injury	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0022 affected64 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0022 affected64 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0014 affected241 at risk EG0021 affected64 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0018 affected241 at risk EG0023 affected64 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0022 affected64 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0023 affected64 at risk EG003
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Vasculitis necrotising	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00031 affected191 at risk EG00148 affected241 at risk EG0027 affected64 at risk EG0030 affected18 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected191 at risk EG00121 affected241 at risk EG0020 affected64 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00031 affected191 at risk EG001102 affected241 at risk EG0025 affected64 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00025 affected191 at risk EG00148 affected241 at risk EG0023 affected64 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0018 affected241 at risk EG0021 affected64 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0016 affected241 at risk EG0021 affected64 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0017 affected241 at risk EG0021 affected64 at risk EG003
Blepharospasm	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Chalazion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Photopsia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG0017 affected241 at risk EG0022 affected64 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0015 affected241 at risk EG0024 affected64 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00014 affected191 at risk EG00131 affected241 at risk EG0028 affected64 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG0017 affected241 at risk EG0025 affected64 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0018 affected241 at risk EG0023 affected64 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected191 at risk EG00149 affected241 at risk EG00211 affected64 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00058 affected191 at risk EG001106 affected241 at risk EG00236 affected64 at risk EG003
Dyschezia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG00115 affected241 at risk EG0023 affected64 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG0019 affected241 at risk EG0024 affected64 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG00111 affected241 at risk EG0024 affected64 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Lip discolouration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00044 affected191 at risk EG00181 affected241 at risk EG00224 affected64 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0013 affected241 at risk EG0021 affected64 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected191 at risk EG00118 affected241 at risk EG0028 affected64 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected191 at risk EG00133 affected241 at risk EG00214 affected64 at risk EG003
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG00016 affected191 at risk EG00121 affected241 at risk EG0027 affected64 at risk EG003
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0015 affected241 at risk EG0024 affected64 at risk EG003
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0019 affected241 at risk EG0020 affected64 at risk EG003
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG00031 affected191 at risk EG00140 affected241 at risk EG00223 affected64 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00063 affected191 at risk EG00185 affected241 at risk EG00221 affected64 at risk EG003
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0029 affected64 at risk EG003
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0014 affected241 at risk EG0026 affected64 at risk EG003
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected191 at risk EG00115 affected241 at risk EG0020 affected64 at risk EG003
Oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0018 affected241 at risk EG0024 affected64 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG00018 affected191 at risk EG00129 affected241 at risk EG0027 affected64 at risk EG003
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG00124 affected241 at risk EG0021 affected64 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00049 affected191 at risk EG00192 affected241 at risk EG00226 affected64 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Candida infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG0015 affected241 at risk EG0020 affected64 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0014 affected241 at risk EG0021 affected64 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG00113 affected241 at risk EG0022 affected64 at risk EG003
Hordeolum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG00111 affected241 at risk EG0023 affected64 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG00118 affected241 at risk EG0027 affected64 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 affected191 at risk EG00122 affected241 at risk EG0026 affected64 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00032 affected191 at risk EG00138 affected241 at risk EG0028 affected64 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 affected191 at risk EG00115 affected241 at risk EG0029 affected64 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0007 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0015 affected241 at risk EG0021 affected64 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG00114 affected241 at risk EG0027 affected64 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00033 affected191 at risk EG00152 affected241 at risk EG00218 affected64 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00035 affected191 at risk EG00147 affected241 at risk EG00218 affected64 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00012 affected191 at risk EG00113 affected241 at risk EG0022 affected64 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0016 affected241 at risk EG0021 affected64 at risk EG003
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00011 affected191 at risk EG0019 affected241 at risk EG0023 affected64 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG00114 affected241 at risk EG0020 affected64 at risk EG003
Blood phosphorus increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Blood uric acid increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0020 affected64 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Liver function test increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG0015 affected241 at risk EG0026 affected64 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG0019 affected241 at risk EG0025 affected64 at risk EG003
Transaminases increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG0015 affected241 at risk EG0029 affected64 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00010 affected191 at risk EG00121 affected241 at risk EG0027 affected64 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00022 affected191 at risk EG00141 affected241 at risk EG0029 affected64 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected191 at risk EG00110 affected241 at risk EG0026 affected64 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected191 at risk EG00112 affected241 at risk EG0024 affected64 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG00110 affected241 at risk EG0024 affected64 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected191 at risk EG00112 affected241 at risk EG0022 affected64 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG00135 affected241 at risk EG0026 affected64 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG00111 affected241 at risk EG0025 affected64 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00016 affected191 at risk EG0017 affected241 at risk EG0021 affected64 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected191 at risk EG0019 affected241 at risk EG0021 affected64 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 affected191 at risk EG00116 affected241 at risk EG00210 affected64 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected191 at risk EG00124 affected241 at risk EG0029 affected64 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0013 affected241 at risk EG0020 affected64 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG0015 affected241 at risk EG0024 affected64 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0014 affected241 at risk EG0021 affected64 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG0015 affected241 at risk EG0024 affected64 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG00110 affected241 at risk EG0024 affected64 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00013 affected191 at risk EG00113 affected241 at risk EG0026 affected64 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00015 affected191 at risk EG00132 affected241 at risk EG0027 affected64 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG00124 affected241 at risk EG0024 affected64 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00022 affected191 at risk EG00131 affected241 at risk EG00215 affected64 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0011 affected241 at risk EG0021 affected64 at risk EG003
Lethargy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Mental impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0020 affected64 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG0019 affected241 at risk EG0022 affected64 at risk EG003
Agitation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0012 affected241 at risk EG0021 affected64 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG00116 affected241 at risk EG0024 affected64 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG0013 affected241 at risk EG0021 affected64 at risk EG003
Emotional disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected191 at risk EG00136 affected241 at risk EG00213 affected64 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG0017 affected241 at risk EG0024 affected64 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG0017 affected241 at risk EG0022 affected64 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0014 affected241 at risk EG0020 affected64 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG0013 affected241 at risk EG0022 affected64 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00036 affected191 at risk EG00181 affected241 at risk EG00221 affected64 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG00110 affected241 at risk EG0021 affected64 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00017 affected191 at risk EG00142 affected241 at risk EG00214 affected64 at risk EG003
Hypopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 affected191 at risk EG00112 affected241 at risk EG0022 affected64 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 affected191 at risk EG00118 affected241 at risk EG0022 affected64 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0016 affected241 at risk EG0020 affected64 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected191 at risk EG00120 affected241 at risk EG0024 affected64 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 affected191 at risk EG00115 affected241 at risk EG0021 affected64 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG0011 affected241 at risk EG0024 affected64 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00023 affected191 at risk EG00123 affected241 at risk EG00210 affected64 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 affected191 at risk EG00129 affected241 at risk EG00211 affected64 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00039 affected191 at risk EG00165 affected241 at risk EG00224 affected64 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0021 affected64 at risk EG003
Flushing	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 affected191 at risk EG00110 affected241 at risk EG0024 affected64 at risk EG003
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected191 at risk EG0012 affected241 at risk EG0022 affected64 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0006 affected191 at risk EG00111 affected241 at risk EG0024 affected64 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0008 affected191 at risk EG0017 affected241 at risk EG0027 affected64 at risk EG003
Thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected191 at risk EG0010 affected241 at risk EG0020 affected64 at risk EG003

ID	Title	Description
BG000	101-02	Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
BG001	101-07	Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.
BG002	101-08	Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.
BG003	101-10	Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.
BG004	Total	Total of all reporting groups

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008228	Lymphoma, Non-Hodgkin

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
D008223	Lymphoma

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	101-02	Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered the long-term safety extension study 101-99 to receive the same treatment.	25	191	100	191	183	191
EG001	101-07	Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment.	36	241	165	241	236	241
EG002	101-08	Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment.	7	45	45	64	63	64
EG003	101-10	Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment.	2	6	6	18	16	18