Study of Ibrutinib and Rituximab in Treatment Naïve Folli... | NCT02947347

ID	Type	Description	Link
2016-003202-14	EudraCT Number
2023-507271-21-00	EU Trial (CTIS) Number

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
(Arm A) ibrutinib + rituximab	Experimental	Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance.	Drug: Ibrutinib Oral Capsule Drug: Rituximab
(Arm B) placebo + rituximab	Placebo Comparator	Participants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance.	Drug: Placebo Drug: Rituximab

Name	Type	Description	Arm Group Labels	Other Names
Ibrutinib Oral Capsule	Drug	Ibrutinib 560mg administered orally daily	(Arm A) ibrutinib + rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator	PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma [Cheson 2014, Lugano Classification]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.	Primary Analysis cut-off; median overall follow-up of 53.75 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR) as Assessed by Investigator	ORR is the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) as determined by the investigator according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014, Lugano Classification). ORR was assessed from the date of randomization through the date of first documented disease progression or initiation of subsequent anti-cancer therapy, whichever occurred first. Participants who did not have any post-baseline disease assessments or who initiated subsequent anti-cancer therapy prior to a documented response are considered non-responders.

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center		Mobile	Alabama	36526	United States
City of Hope

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42317205	Derived	Belada D, Gardner FP, de Oliveira AC, Sancho JM, Lomaia E, Wright D, Turgut M, Martynova E, Lazar Z, Anz B, Wang MC, Legiec W, Opat S, Pailden J, Peltier HM, Marturano E, Dean JP, Flinn IW. Phase 3 PERSPECTIVE study: Ibrutinib with rituximab for initial treatment of patients with follicular lymphoma. Hemasphere. 2026 Jun 17;10(6):e70400. doi: 10.1002/hem3.70400. eCollection 2026 Jun.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 10, 2024	Feb 19, 2026

Arm/Group Information

ID	Title	Description
BG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
BG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00073.7± 6.38 BG00174.2± 5.96 BG00273.8± 6.28

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000183 BG00153 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00019 BG0018 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS) as Assessed by Investigator

PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma [Cheson 2014, Lugano Classification]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.

ITT Population. Participants achieving response (partial response or better) who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored.

Posted

Median

95% Confidence Interval

months

Primary Analysis cut-off; median overall follow-up of 53.75 months

ID	Title	Description
OG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000334 OG001111

Title

Denominators

Categories

Title	Measurements
	OG00042.02(33.31 to 50.83) OG00132.76(22.05 to 38.67)

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	A stratified log-rank test was used to compare PFS between the two arms. The stratification was based on FLIPI-1 and ECOG reported at randomization combined into a 3 strata variable: FLIPI-1 score=low; FLIPI-1 score=intermediate/high and ECOG performance status score=0/1; FLIPI-1 score=intermediate/high and ECOG performance status score=2.	Log Rank		0.0231		Hazard Ratio (HR)	0.713			2-Sided	95	0.532	0.955					Superiority

Secondary

Overall Response Rate (ORR) as Assessed by Investigator

ORR is the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) as determined by the investigator according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014, Lugano Classification). ORR was assessed from the date of randomization through the date of first documented disease progression or initiation of subsequent anti-cancer therapy, whichever occurred first. Participants who did not have any post-baseline disease assessments or who initiated subsequent anti-cancer therapy prior to a documented response are considered non-responders.

ITT population

Posted

Number

95% Confidence Interval

percentage of participants

Primary Analysis; median overall follow-up of 53.75 months

ID	Title	Description
OG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Overall Survival (OS)

Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause. If a participant is not known to have died (this includes participants with unknown death date), OS will be censored at the date the participant was last known to have been alive. Estimated by Kaplan-Meier method.

ITT Population

Posted

Median

95% Confidence Interval

months

Final Analysis; median overall follow-up of 58.97 months

ID	Title	Description
OG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Infusion-related Reaction Rate Assessed by Investigator

The infusion-related reactions (IRR) rate is the proportion of subjects experiencing infusion related reactions that start on the day of a rituximab infusion and are assessed as related or possibly related to rituximab.

ITT Population

Posted

Number

95% Confidence Interval

percentage of participants

Primary Analysis; median overall follow-up of 53.75 months

ID	Title	Description
OG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Duration of Response (DOR) as Assessed by Investigator

DOR is defined as the time from initial complete response (CR) or partial response (PR) to progressive disease (PD) or death due to any cause, whichever is first reported, regardless of discontinuation of study treatment. If such event did not occur, then participants were to be censored at the last adequate disease assessment as required for PFS censoring. Estimated by Kaplan-Meier method.

ITT Population. Participants achieving a response (partial response or better) are included in this analysis. Participants achieving response (partial response or better) who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored.

Posted

Median

95% Confidence Interval

months

Primary Analysis; median overall follow-up of 53.75 months

ID	Title	Description
OG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The treatment-emergent period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent anti-cancer therapy, whichever comes first. The treatment-emergent adverse events (TEAEs) are those events that occur or worsen during the treatment-emergent period or that are related to the study treatment.

Safety Population

Posted

Count of Participants

Participants

Overall median treatment duration of 22.11 months

ID	Title	Description
OG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: Ibrutinib + Rituximab	Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.	123	334	214	334	310	334
EG001	Arm B: Placebo + Rituximab	Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent.	40	111	48	111	101	111

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0010 events0 affected111 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected334 at risk EG0010 events0 affected111 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG00021 events21 affected334 at risk EG0012 events2 affected111 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected334 at risk EG0011 events1 affected111 at risk
CARDIAC ASTHMA	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected334 at risk EG0011 events1 affected111 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected334 at risk EG0011 events1 affected111 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CHRONIC CORONARY SYNDROME	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0003 events1 affected334 at risk EG0010 events0 affected111 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
PERICARDITIS	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected334 at risk EG0010 events0 affected111 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
LABYRINTHINE FISTULA	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0011 events1 affected111 at risk
EPIRETINAL MEMBRANE	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
NEOVASCULAR AGE-RELATED MACULAR DEGENERATION	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RETINAL HAEMORRHAGE	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
VITREOUS HAEMORRHAGE	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0012 events1 affected111 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ASCITES	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
COLITIS	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events2 affected334 at risk EG0010 events0 affected111 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected334 at risk EG0011 events1 affected111 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
GASTROINTESTINAL POLYP HAEMORRHAGE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
INCARCERATED INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
OBSTRUCTIVE PANCREATITIS	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0010 events0 affected111 at risk
PANCREATOLITHIASIS	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PNEUMATOSIS INTESTINALIS	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0011 events1 affected111 at risk
VOMITING	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected334 at risk EG0010 events0 affected111 at risk
ASTHENIA	General disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0010 events0 affected111 at risk
CHEST PAIN	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0012 events1 affected111 at risk
CHILLS	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
DEATH	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0012 events2 affected111 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected334 at risk EG0012 events1 affected111 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
PYREXIA	General disorders	MedDRA 27.0	Systematic Assessment	EG0008 events6 affected334 at risk EG0010 events0 affected111 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BILIARY OBSTRUCTION	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
HEPATIC CYTOLYSIS	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ABDOMINAL INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
APPENDICITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BACTERAEMIA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BRONCHITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0011 events1 affected111 at risk
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0011 events1 affected111 at risk
CAMPYLOBACTER GASTROENTERITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CAMPYLOBACTER INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CANDIDA SEPSIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CARBUNCLE	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CELLULITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected334 at risk EG0010 events0 affected111 at risk
CENTRAL NERVOUS SYSTEM FUNGAL INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00031 events25 affected334 at risk EG0011 events1 affected111 at risk
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00035 events21 affected334 at risk EG0016 events5 affected111 at risk
CYCLOSPORIDIUM INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CYSTITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
DIABETIC FOOT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ENTEROCOLITIS INFECTIOUS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ERYSIPELAS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0011 events1 affected111 at risk
GANGRENE	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0012 events2 affected111 at risk
GASTROENTERITIS ROTAVIRUS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HEPATITIS B REACTIVATION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0011 events1 affected111 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
INFLUENZA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0012 events2 affected111 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
MENINGITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PHARYNGITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PNEUMONIA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00045 events36 affected334 at risk EG0015 events5 affected111 at risk
PNEUMONIA ASPIRATION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PROSTATITIS ESCHERICHIA COLI	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PROTEUS INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0005 events5 affected334 at risk EG0010 events0 affected111 at risk
SEPSIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0012 events1 affected111 at risk
SEPSIS PASTEURELLA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected334 at risk EG0010 events0 affected111 at risk
SPLENIC ABSCESS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SPONTANEOUS BACTERIAL PERITONITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0010 events0 affected111 at risk
STENOTROPHOMONAS INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected334 at risk EG0010 events0 affected111 at risk
SUPERINFECTION BACTERIAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
TONSILLITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0011 events1 affected111 at risk
URINARY TRACT CANDIDIASIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00012 events11 affected334 at risk EG0014 events4 affected111 at risk
URINARY TRACT INFECTION ENTEROCOCCAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
URINARY TRACT INFECTION PSEUDOMONAL	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
UROSEPSIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
WOUND INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CRANIOFACIAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
EXTRA-AXIAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected334 at risk EG0010 events0 affected111 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0011 events1 affected111 at risk
FRACTURE DISPLACEMENT	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected334 at risk EG0011 events1 affected111 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0012 events2 affected111 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0012 events2 affected111 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
URETERIC INJURY	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
OCCULT BLOOD POSITIVE	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0011 events1 affected111 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ADENOCARCINOMA GASTRIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0013 events2 affected111 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
BOWEN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BREAST CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CANCER FATIGUE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
FOLLICULAR LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0005 events3 affected334 at risk EG0011 events1 affected111 at risk
INVASIVE DUCTAL BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
INVASIVE LOBULAR BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
METASTASES TO PERITONEUM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0013 events1 affected111 at risk
METASTATIC RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
NASAL CAVITY CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
OROPHARYNGEAL NEOPLASM BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected334 at risk EG0010 events0 affected111 at risk
PROSTATE CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RENAL CELL CARCINOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SIGNET-RING CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0012 events1 affected111 at risk
TRANSITIONAL CELL CANCER OF THE RENAL PELVIS AND URETER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
TUMOUR NECROSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
BASAL GANGLIA HAEMORRHAGE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
BRAIN OEDEMA	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0010 events0 affected111 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HAEMORRHAGIC TRANSFORMATION STROKE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
INTRACRANIAL HAEMATOMA	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0007 events6 affected334 at risk EG0011 events1 affected111 at risk
SCIATICA	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0011 events1 affected111 at risk
STIFF PERSON SYNDROME	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SYNCOPE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0010 events0 affected111 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected334 at risk EG0012 events2 affected111 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
DELIRIUM	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
DEPRESSION	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0007 events6 affected334 at risk EG0010 events0 affected111 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
DYSURIA	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
RENAL HAEMATOMA	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
RENAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0003 events1 affected334 at risk EG0010 events0 affected111 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected334 at risk EG0010 events0 affected111 at risk
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PROSTATITIS	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
UTERINE MASS	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0012 events2 affected111 at risk
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected334 at risk EG0013 events2 affected111 at risk
CHYLOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0012 events1 affected111 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected334 at risk EG0010 events0 affected111 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected334 at risk EG0010 events0 affected111 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ORGANISING PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0008 events5 affected334 at risk EG0013 events3 affected111 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0011 events1 affected111 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RESPIRATORY ACIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0006 events4 affected334 at risk EG0010 events0 affected111 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
BLISTER	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
ISCHAEMIC SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
SKIN DISCHARGE	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
TOXIC SKIN ERUPTION	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
EMBOLISM	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HYPERTENSION	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
NEUROGENIC SHOCK	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
PERIPHERAL VENOUS DISEASE	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected334 at risk EG0010 events0 affected111 at risk
THROMBOSIS	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected334 at risk EG0011 events1 affected111 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00083 events49 affected334 at risk EG00113 events9 affected111 at risk
INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00040 events31 affected334 at risk EG0010 events0 affected111 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG000118 events67 affected334 at risk EG00115 events12 affected111 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG00072 events31 affected334 at risk EG0011 events1 affected111 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG00039 events36 affected334 at risk EG0011 events1 affected111 at risk
CATARACT	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00030 events26 affected334 at risk EG0018 events6 affected111 at risk
DRY EYE	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00084 events60 affected334 at risk EG00126 events17 affected111 at risk
EYE IRRITATION	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00056 events41 affected334 at risk EG00126 events18 affected111 at risk
EYE PAIN	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00027 events23 affected334 at risk EG00111 events7 affected111 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00058 events40 affected334 at risk EG00122 events13 affected111 at risk
PHOTOPHOBIA	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00041 events32 affected334 at risk EG00113 events7 affected111 at risk
PHOTOPSIA	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00018 events13 affected334 at risk EG00113 events7 affected111 at risk
VISION BLURRED	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00074 events53 affected334 at risk EG00119 events10 affected111 at risk
VISUAL ACUITY REDUCED	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00055 events39 affected334 at risk EG00127 events17 affected111 at risk
VITREOUS FLOATERS	Eye disorders	MedDRA 27.0	Systematic Assessment	EG00034 events26 affected334 at risk EG00117 events12 affected111 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00042 events32 affected334 at risk EG0017 events6 affected111 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00031 events27 affected334 at risk EG0019 events9 affected111 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00065 events53 affected334 at risk EG00118 events16 affected111 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000205 events116 affected334 at risk EG00119 events15 affected111 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00019 events16 affected334 at risk EG0019 events7 affected111 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00092 events69 affected334 at risk EG00118 events12 affected111 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00041 events26 affected334 at risk EG0012 events2 affected111 at risk
VOMITING	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00062 events41 affected334 at risk EG0015 events5 affected111 at risk
ASTHENIA	General disorders	MedDRA 27.0	Systematic Assessment	EG00044 events35 affected334 at risk EG0017 events7 affected111 at risk
CHILLS	General disorders	MedDRA 27.0	Systematic Assessment	EG00015 events12 affected334 at risk EG0019 events8 affected111 at risk
FATIGUE	General disorders	MedDRA 27.0	Systematic Assessment	EG000120 events72 affected334 at risk EG00125 events16 affected111 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 27.0	Systematic Assessment	EG00095 events63 affected334 at risk EG00122 events18 affected111 at risk
PYREXIA	General disorders	MedDRA 27.0	Systematic Assessment	EG00042 events35 affected334 at risk EG00121 events15 affected111 at risk
BRONCHITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00027 events23 affected334 at risk EG0014 events4 affected111 at risk
CONJUNCTIVITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00025 events21 affected334 at risk EG0015 events5 affected111 at risk
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00074 events62 affected334 at risk EG00126 events22 affected111 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00018 events14 affected334 at risk EG0017 events6 affected111 at risk
PNEUMONIA	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00024 events20 affected334 at risk EG0015 events4 affected111 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00041 events27 affected334 at risk EG00110 events6 affected111 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG000122 events60 affected334 at risk EG00113 events10 affected111 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG00036 events33 affected334 at risk EG00112 events11 affected111 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG00031 events27 affected334 at risk EG00118 events16 affected111 at risk
WEIGHT DECREASED	Investigations	MedDRA 27.0	Systematic Assessment	EG00021 events17 affected334 at risk EG0015 events4 affected111 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00036 events34 affected334 at risk EG0014 events4 affected111 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00035 events27 affected334 at risk EG0016 events6 affected111 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00054 events35 affected334 at risk EG0015 events3 affected111 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00083 events63 affected334 at risk EG00124 events16 affected111 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00054 events45 affected334 at risk EG00115 events15 affected111 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00052 events39 affected334 at risk EG00110 events8 affected111 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00026 events22 affected334 at risk EG0017 events6 affected111 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00033 events30 affected334 at risk EG0019 events6 affected111 at risk
DIZZINESS	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00037 events32 affected334 at risk EG0015 events5 affected111 at risk
HEADACHE	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00071 events45 affected334 at risk EG0016 events5 affected111 at risk
INSOMNIA	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG00028 events27 affected334 at risk EG00113 events12 affected111 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00072 events57 affected334 at risk EG00122 events17 affected111 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00045 events38 affected334 at risk EG00129 events20 affected111 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG00031 events24 affected334 at risk EG0013 events3 affected111 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected334 at risk EG0017 events6 affected111 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00020 events20 affected334 at risk EG0013 events3 affected111 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00018 events17 affected334 at risk EG0013 events2 affected111 at risk
ONYCHOCLASIS	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00018 events17 affected334 at risk EG0010 events0 affected111 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00036 events26 affected334 at risk EG00114 events13 affected111 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00031 events22 affected334 at risk EG0012 events1 affected111 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG00045 events31 affected334 at risk EG0015 events4 affected111 at risk
HYPERTENSION	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG00076 events48 affected334 at risk EG00114 events10 affected111 at risk
HYPOTENSION	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG00011 events9 affected334 at risk EG0017 events6 affected111 at risk

ID	Term
D008224	Lymphoma, Follicular
D008228	Lymphoma, Non-Hodgkin

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins