Study of Pembrolizumab (MK-3475) vs Standard Therapy in P... | NCT02563002

ID	Type	Description
163238	Registry Identifier	JAPIC-CTI
MK-3475-177	Other Identifier	MSD
KEYNOTE-177	Other Identifier	MSD
2015-002024-89	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab	Experimental	Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Participants that have stopped the initial course of pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional).	Biological: Pembrolizumab
Standard of Care (SOC)	Active Comparator	Participants receive 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Participants that have stopped pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional).	Drug: mFOLFOX6 Drug: FOLFIRI Biological: Pembrolizumab Biological: Bevacizumab Biological: Cetuximab

Name	Type	Description	Arm Group Labels	Other Names
mFOLFOX6	Drug	Regimen consists of oxaliplatin 85 mg/m^2 IV on Day 1, leucovorin 400 mg/m^2 or levoleucovorin 200 mg/m^2 IV on Day 1, 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus on Day 1 and then 1200 mg/m^2/day IV over 2 days for total dose of 2400 mg/m^2 in each 2-week cycle

Measure	Description	Time Frame
Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor	PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.	Up to approximately 59 months
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. HR and associated 95% CIs from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.	Up to approximately 59 months

Measure	Description	Time Frame
Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor	ORR was defined as the percentage of the participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 as assessed by the central imaging vendor. The percentage of participants who experienced a CR or PR was presented for the first course of study treatment per protocol.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
36369901	Derived	Yoshino T, Andre T, Kim TW, Yong WP, Shiu KK, Jensen BV, Jensen LH, Punt CJA, Smith D, Garcia-Carbonero R, Alcaide-Garcia J, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Le DT, Adachi N, Fogelman D, Marinello P, Diaz LA Jr. Pembrolizumab in Asian patients with microsatellite-instability-high/mismatch-repair-deficient colorectal cancer. Cancer Sci. 2023 Mar;114(3):1026-1036. doi: 10.1111/cas.15650. Epub 2022 Dec 12.
35427471

Label	URL
Merck Clinical Trial Information	View source

ID	Title	Description
FG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 12, 2022

ID	Title	Description
BG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
BG001	Standard of Care (SOC)	Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000153 BG001154 BG002307

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) Per RECIST1.1 As Assessed by Central Imaging Vendor

PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.

All randomized participants

Posted

Median

95% Confidence Interval

Months

Up to approximately 59 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
OG001	Standard of Care (SOC)	Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

Units	Counts
Participants	OG000153 OG001154

Title

Denominators

Categories

Title	Measurements
	OG00016.5(5.4 to 38.1) OG0018.2(6.1 to 10.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	One-sided p-value based on log rank test	0.0001		Hazard Ratio (HR)	0.59			2-Sided	95	0.45	0.79			Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.		Other

Primary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. HR and associated 95% CIs from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course study treatment per protocol.

All randomized participants

Posted

Median

95% Confidence Interval

Months

Up to approximately 59 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
OG001	Standard of Care (SOC)	Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

Secondary

Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor

ORR was defined as the percentage of the participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 as assessed by the central imaging vendor. The percentage of participants who experienced a CR or PR was presented for the first course of study treatment per protocol.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 59 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
OG001	Standard of Care (SOC)	Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE was presented for the first course study treatment per protocol.

All participants who received at least 1 dose of study treatment

Posted

Count of Participants

Participants

Up to approximately 59 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
OG001	Standard of Care (SOC)

Secondary

Number of Participants Who Discontinued Study Treatment Due to an AE

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE was presented for the first course study treatment per protocol.

All participants who received at least 1 dose of study treatment

Posted

Count of Participants

Participants

Up to approximately 59 months

ID	Title	Description
OG000	Pembrolizumab	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
OG001	Standard of Care (SOC)

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG0030 events0 affected12 at risk EG0040 events0 affected5 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0016 events6 affected143 at risk EG0020 events0 affected57 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events3 affected143 at risk EG0020 events0 affected57 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Addison's disease	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Angle closure glaucoma	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Vision blurred	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events7 affected153 at risk EG0012 events2 affected143 at risk EG0022 events2 affected57 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Autoimmune colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected153 at risk EG0019 events9 affected143 at risk EG0021 events1 affected57 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Duodenal perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0013 events3 affected143 at risk EG0021 events1 affected57 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Short-bowel syndrome	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0019 events5 affected143 at risk EG0023 events3 affected57 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0014 events4 affected143 at risk EG0020 events0 affected57 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Device related thrombosis	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events3 affected143 at risk EG0020 events0 affected57 at risk EG003
Gait disturbance	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
General physical health deterioration	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Mucosal inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Device related infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events2 affected143 at risk EG0021 events1 affected57 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Endophthalmitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Escherichia pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Lymph gland infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Meningoencephalitis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Pelvic infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0012 events2 affected143 at risk EG0022 events2 affected57 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0021 events1 affected57 at risk EG003
Stoma site abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Stoma site infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0021 events1 affected57 at risk EG003
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Vascular device infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Viral infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Urinary tract stoma complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Liver function test increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Norovirus test positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0013 events3 affected143 at risk EG0020 events0 affected57 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0017 events4 affected143 at risk EG0020 events0 affected57 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0021 events1 affected57 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Autoimmune arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Oropharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0004 events2 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Vaginal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Amnesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Occipital neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Pseudobulbar palsy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0012 events2 affected143 at risk EG0023 events3 affected57 at risk EG003
Autoimmune nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Glomerulonephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Prerenal failure	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0014 events4 affected143 at risk EG0021 events1 affected57 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Embolism	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG00032 events26 affected153 at risk EG00140 events33 affected143 at risk EG00218 events9 affected57 at risk EG0031 events1 affected12 at risk EG0040 events0 affected5 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG00112 events3 affected143 at risk EG0020 events0 affected57 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected153 at risk EG00152 events27 affected143 at risk EG0020 events0 affected57 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG00118 events8 affected143 at risk EG0020 events0 affected57 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected153 at risk EG0012 events2 affected143 at risk EG0020 events0 affected57 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected153 at risk EG0010 events0 affected143 at risk EG0026 events6 affected57 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00020 events19 affected153 at risk EG0016 events4 affected143 at risk EG0027 events7 affected57 at risk EG003
Dry eye	Eye disorders	MedDRA 26.0	Systematic Assessment	EG00011 events9 affected153 at risk EG0014 events3 affected143 at risk EG0020 events0 affected57 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Vision blurred	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected153 at risk EG0012 events2 affected143 at risk EG0021 events1 affected57 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00056 events34 affected153 at risk EG00162 events41 affected143 at risk EG00212 events8 affected57 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00021 events19 affected153 at risk EG00114 events11 affected143 at risk EG0023 events2 affected57 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0013 events3 affected143 at risk EG0023 events3 affected57 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00030 events26 affected153 at risk EG00176 events45 affected143 at risk EG00219 events13 affected57 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000107 events65 affected153 at risk EG001204 events89 affected143 at risk EG00236 events17 affected57 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00018 events17 affected153 at risk EG00110 events9 affected143 at risk EG0025 events4 affected57 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00010 events9 affected153 at risk EG00121 events16 affected143 at risk EG0027 events5 affected57 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected153 at risk EG0018 events6 affected143 at risk EG0021 events1 affected57 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG00110 events10 affected143 at risk EG0020 events0 affected57 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00069 events47 affected153 at risk EG001283 events85 affected143 at risk EG00223 events16 affected57 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected153 at risk EG00175 events43 affected143 at risk EG0024 events4 affected57 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00053 events33 affected153 at risk EG00185 events53 affected143 at risk EG00220 events12 affected57 at risk EG003
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG00032 events19 affected153 at risk EG00157 events30 affected143 at risk EG0028 events5 affected57 at risk EG003
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected153 at risk EG0014 events3 affected143 at risk EG0025 events4 affected57 at risk EG003
Chills	General disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected153 at risk EG0019 events7 affected143 at risk EG0020 events0 affected57 at risk EG003
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00079 events58 affected153 at risk EG001176 events70 affected143 at risk EG0029 events9 affected57 at risk EG003
Impaired healing	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Influenza like illness	General disorders	MedDRA 26.0	Systematic Assessment	EG00020 events14 affected153 at risk EG0014 events4 affected143 at risk EG0023 events3 affected57 at risk EG003
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected153 at risk EG0018 events6 affected143 at risk EG0021 events1 affected57 at risk EG003
Mucosal inflammation	General disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected153 at risk EG00149 events27 affected143 at risk EG0022 events2 affected57 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG00024 events18 affected153 at risk EG00113 events11 affected143 at risk EG00211 events10 affected57 at risk EG003
Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected153 at risk EG0013 events3 affected143 at risk EG0020 events0 affected57 at risk EG003
Peripheral swelling	General disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected153 at risk EG0010 events0 affected143 at risk EG0023 events3 affected57 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00029 events24 affected153 at risk EG00128 events20 affected143 at risk EG0029 events7 affected57 at risk EG003
Temperature intolerance	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected153 at risk EG00112 events8 affected143 at risk EG0020 events0 affected57 at risk EG003
Candida infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0020 events0 affected57 at risk EG003
Cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected153 at risk EG0018 events5 affected143 at risk EG0026 events4 affected57 at risk EG003
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected153 at risk EG0014 events4 affected143 at risk EG0021 events1 affected57 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00031 events20 affected153 at risk EG00113 events10 affected143 at risk EG00212 events8 affected57 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected153 at risk EG0016 events6 affected143 at risk EG0025 events4 affected57 at risk EG003
Paronychia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG00117 events8 affected143 at risk EG0020 events0 affected57 at risk EG003
Tooth infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected153 at risk EG0015 events5 affected143 at risk EG0021 events1 affected57 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00017 events16 affected153 at risk EG00111 events8 affected143 at risk EG0022 events2 affected57 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00019 events14 affected153 at risk EG00123 events15 affected143 at risk EG0029 events7 affected57 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00013 events11 affected153 at risk EG0015 events5 affected143 at risk EG0022 events2 affected57 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00033 events22 affected153 at risk EG00130 events16 affected143 at risk EG0026 events5 affected57 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00033 events24 affected153 at risk EG00124 events12 affected143 at risk EG0026 events6 affected57 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00030 events22 affected153 at risk EG0019 events6 affected143 at risk EG0022 events2 affected57 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected153 at risk EG0015 events4 affected143 at risk EG0022 events2 affected57 at risk EG003
Cardiac murmur	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected143 at risk EG0021 events1 affected57 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected153 at risk EG0015 events3 affected143 at risk EG0022 events1 affected57 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG00165 events32 affected143 at risk EG00210 events2 affected57 at risk EG003
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0004 events2 affected153 at risk EG00129 events10 affected143 at risk EG0023 events2 affected57 at risk EG003
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected153 at risk EG00117 events17 affected143 at risk EG0022 events2 affected57 at risk EG003
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG00148 events17 affected143 at risk EG0026 events2 affected57 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00049 events36 affected153 at risk EG001114 events57 affected143 at risk EG0022 events2 affected57 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected153 at risk EG0017 events7 affected143 at risk EG0021 events1 affected57 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0022 events2 affected57 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00024 events8 affected153 at risk EG0014 events4 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected153 at risk EG00118 events9 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00025 events13 affected153 at risk EG00138 events23 affected143 at risk EG0024 events2 affected57 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00011 events10 affected153 at risk EG0017 events6 affected143 at risk EG0024 events3 affected57 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00052 events31 affected153 at risk EG00111 events10 affected143 at risk EG00218 events12 affected57 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00029 events25 affected153 at risk EG00127 events24 affected143 at risk EG00213 events11 affected57 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected153 at risk EG0017 events5 affected143 at risk EG0023 events3 affected57 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected153 at risk EG0011 events1 affected143 at risk EG0023 events3 affected57 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected153 at risk EG00115 events12 affected143 at risk EG0027 events3 affected57 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected153 at risk EG0015 events5 affected143 at risk EG0021 events1 affected57 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00021 events18 affected153 at risk EG00111 events11 affected143 at risk EG0027 events6 affected57 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00029 events24 affected153 at risk EG00154 events27 affected143 at risk EG00210 events6 affected57 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected153 at risk EG00114 events13 affected143 at risk EG0020 events0 affected57 at risk EG003
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00026 events21 affected153 at risk EG00137 events22 affected143 at risk EG00227 events17 affected57 at risk EG003
Hemiparaesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0017 events5 affected143 at risk EG0020 events0 affected57 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG00141 events28 affected143 at risk EG0024 events4 affected57 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0007 events6 affected153 at risk EG00110 events8 affected143 at risk EG0021 events1 affected57 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected153 at risk EG00151 events31 affected143 at risk EG0021 events1 affected57 at risk EG003
Anger	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00011 events9 affected153 at risk EG0016 events4 affected143 at risk EG0024 events4 affected57 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected153 at risk EG0015 events5 affected143 at risk EG0023 events3 affected57 at risk EG003
Discouragement	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00014 events12 affected153 at risk EG00111 events10 affected143 at risk EG0027 events7 affected57 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected153 at risk EG00128 events11 affected143 at risk EG0025 events2 affected57 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected143 at risk EG0021 events1 affected57 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00031 events26 affected153 at risk EG00126 events23 affected143 at risk EG0029 events7 affected57 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected153 at risk EG0019 events8 affected143 at risk EG0020 events0 affected57 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00025 events20 affected153 at risk EG00122 events15 affected143 at risk EG0028 events6 affected57 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected153 at risk EG00130 events23 affected143 at risk EG0022 events2 affected57 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected153 at risk EG00110 events8 affected143 at risk EG0021 events1 affected57 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected153 at risk EG0018 events8 affected143 at risk EG0023 events3 affected57 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected153 at risk EG0017 events6 affected143 at risk EG0026 events5 affected57 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00010 events9 affected153 at risk EG00115 events13 affected143 at risk EG0021 events1 affected57 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected153 at risk EG00132 events29 affected143 at risk EG0020 events0 affected57 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0006 events3 affected153 at risk EG00122 events8 affected143 at risk EG0021 events1 affected57 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00021 events19 affected153 at risk EG00115 events14 affected143 at risk EG00211 events9 affected57 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected153 at risk EG00135 events25 affected143 at risk EG0021 events1 affected57 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00037 events25 affected153 at risk EG00116 events12 affected143 at risk EG00224 events15 affected57 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00012 events4 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00027 events19 affected153 at risk EG00122 events16 affected143 at risk EG00212 events10 affected57 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected153 at risk EG0013 events3 affected143 at risk EG0022 events2 affected57 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG00110 events8 affected143 at risk EG0022 events1 affected57 at risk EG003
Superficial inflammatory dermatosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0010 events0 affected143 at risk EG0020 events0 affected57 at risk EG003
Embolism	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected153 at risk EG0017 events7 affected143 at risk EG0020 events0 affected57 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00025 events19 affected153 at risk EG00123 events16 affected143 at risk EG0022 events2 affected57 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected153 at risk EG0013 events3 affected143 at risk EG0025 events5 affected57 at risk EG003

ID	Term
D015179	Colorectal Neoplasms
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab First Course	Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years).	68	153	62	153	145	153
EG001	Standard of Care (SOC) First Course	Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m^2 IV over 2 hours then 250 mg/m^2 over 1 hour weekly in each 2-week cycle.	58	154	76	143	142	143
EG002	SOC Switched Over to Pembrolizumab	Eligible participants with documented disease progression following chemotherapy in SOC arm switched over to receive pembrolizumab for up to 35 cycles (approximately 2 years).	30	57	27	57	53	57
EG003	Pembrolizumab Second Course	Participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).	4	12	3	12	11	12
EG004	SOC Switched Over to Pembrolizumab-Second Course	Participants who switched over from SOC and received pembrolizumab and subsequently stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).	2	5	1	5	4	5

ID	Term
C480833	IFL protocol
C582435	pembrolizumab
D000068258	Bevacizumab
D000068818	Cetuximab