A Study Investigating the Efficacy and Safety of Alcestob... | NCT05609370

ID	Type	Description	Link
CTR20223077	Registry Identifier	ChinaDrugTrials

Label	Type	Description	Intervention Names
Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Experimental	Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.	Drug: Alcestobart Drug: Tislelizumab Drug: Bevacizumab or Bevacizumab biosimilar Drug: Fluoropyrimidine (FP)
Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Experimental	Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	Drug: Alcestobart Drug: Tislelizumab Drug: Bevacizumab or Bevacizumab biosimilar Drug: Fluoropyrimidine (FP)
Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Experimental	Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	Drug: Alcestobart Drug: Tislelizumab Drug: Bevacizumab or Bevacizumab biosimilar Drug: Fluoropyrimidine (FP)
Phase 2: Arm A:PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine

Name	Type	Description	Arm Group Labels	Other Names
Alcestobart	Drug	Administered intravenously (IV) at one of the following doses Low dose: 150 mg once every 3 weeks Medium dose: 300 mg once every 3 weeks or 200 mg once every 2 weeks High dose: 600 mg once every 3 weeks or 400 mg once every 2 weeks

Measure	Description	Time Frame
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose- resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect.	From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.
Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C	PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.	From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

Measure	Description	Time Frame
Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C	ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Name	Affiliation	Role
Study Director	BeiGene	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Oncology and Hematology, Llc		Anchorage	Alaska	99508-2974	United States
Banner Md Anderson Cancer Center

ID	Title	Description
FG000	Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
FG001	Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 26, 2025	May 15, 2026

Arm/Group Information

ID	Title	Description
BG000	Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
BG001	Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)
BG002	Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
BG003	Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
BG004	Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
BG005	Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
BG006	Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
BG007	Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine	PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
BG008	Total	Total of all reporting groups

Type

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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

Phase 1b: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose-

resulted in death,
was life threatening,
required hospitalization or prolongation of existing hospitalization,
resulted in disability/incapacity,
was a congenital anomaly/birth defect.

Phase 1b safety analysis population: All participants who have received ≥ 1 dose of any component of study treatment.

Posted

Count of Participants

Participants

From first dose of study drug up to 30 days after last dose; maximum time on treatment was 16.2 months.

ID	Title	Description
OG000	Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.
OG001	Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG002	Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen)

Units	Counts
Participants	OG0006 OG00113 OG0026

Title

Denominators

Categories

Treatment emergent adverse event

Title	Measurements
	OG0006 OG00113 OG0026

Serious adverse event

Primary

Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C

PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occured first.

ITT Analysis Set of Arms A and C for PD-L1-positive population.

Posted

Median

95% Confidence Interval

months

From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

ID	Title	Description
OG000	Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

Secondary

Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Positive Arms A and C

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ITT Analysis Set of Arms A and C for PD-L1-positive population.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm A, 11.0 months, Arm C, 8.0 months)

ID	Title	Description
OG000	Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

Secondary

Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Positive Arms A and C

DOR is defined as the time from the first determination of an objective confirmed response after randomization until the first documentation of disease progression or death, whichever comes first.

ITT Analysis Set of Arms A and C for PD-L1-positive population. Only patients with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis.

Posted

Median

95% Confidence Interval

months

From first documented response until disease progression or death (maximum follow-up time for DOR was 4.2 months)

ID	Title	Description
OG000	Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

Secondary

Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Negative Arms D and E

PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.

ITT Analysis Set of Arms D and E for PD-L1 negative population.

Posted

Median

95% Confidence Interval

months

From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months)

ID	Title	Description
OG000	Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine	PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine	PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

Secondary

Phase 2: Objective Response Rate (ORR) as Assessed by The Investigator in PD-L1 Negative Arms D and E

ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) from the time of randomization. CR and PR were confirmed per RECIST v1.1.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ITT Analysis Set of Arms D and E for PD-L1 negative population.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization until disease progression, death, study discontinuation, or data cutoff, whichever occurred first (maximum follow-up time: Arm D, 10.6 months, Arm E, 10.5 months))

ID	Title	Description
OG000	Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine	PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine	PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

Secondary

Phase 2: Duration of Response (DOR) as Assessed by The Investigator in PD-L1 Negative Arms D and E

DOR, defined as the time from the first confirmed objective response after randomization until the first documentation of disease progression or death, whichever comes first.

ITT Analysis Set of Arms D and E for PD-L1 negative population.

Posted

Median

95% Confidence Interval

months

From first documented response until disease progression or death (maximum follow-up time for DOR was 2.8 months)

ID	Title	Description
OG000	Phase 2: Arm D: PD-L1-negative: Alcestobart High Dose+ Tislelizumab+ Bevacizumab+ Fluoropyrimidine	PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine	PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

Secondary

Phase 2: Number of Participants With Treatment-emergent AEs and SAEs

resulted in death,
was life threatening,
required hospitalization or prolongation of existing hospitalization,
resulted in disability/incapacity,
was a congenital anomaly/birth defect.

Phase 2 safety analysis population: All participants who have received ≥ 1 dose of any component of study treatment.

Posted

Count of Participants

Participants

From first dose of study drug up to 30 days after last dose; maximum time on treatment in Phase 2 was 10.9 months

ID	Title	Description
OG000	Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab + Bevacizumab +Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).
OG001	Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).

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	Phase 1b: Alcestobart Low Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart low dose, tislelizumab, bevacizumab and capecitabine until disease progression, unacceptable toxicity, or withdrawal of consent.	1	6	3	6	6	6
EG001	Phase 1b: Alcestobart Medium Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart medium dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	3	13	8	13	13	13
EG002	Phase 1b: Alcestobart High Dose + Tislelizumab + Bevacizumab + Fluoropyrimidine	Participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	1	6	3	6	6	6
EG003	Phase 2: Arm A: PD-L1-positive: Alcestobart High Dose +Tislelizumab +Bevacizumab +Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	0	18	3	18	17	18
EG004	Phase 2: Arm B: PD-L1-positive: Alcestobart High Dose + Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received alcestobart high dose, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	0	9	1	9	9	9
EG005	Phase 2: Arm C: PD-L1-positive: Bevacizumab + Fluoropyrimidine	PD-L1-positive participants received bevacizumab and fluoropyrimidine in combination with leucovorin or levoleucovorin (LV) until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	0	16	3	14	12	14
EG006	Phase 2:Arm D:PD-L1-negative: Alcestobart High Dose + Tislelizumab+ Bevacizumab+ Fluoropyrimidine	PD-L1-negative participants received alcestobart high dose, tislelizumab, bevacizumab and fluoropyrimidine until disease progression, unacceptable toxicity, or withdrawal of consent. The alcestobart, tislelizumab, and bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	2	22	7	22	21	22
EG007	Phase 2: Arm E: PD-L1-negative: Bevacizumab + Fluoropyrimidine	PD-L1-negative participants received bevacizumab and fluoropyrimidine in combination with LV until disease progression, unacceptable toxicity, or withdrawal of consent. The bevacizumab dosing frequency was based on the selected fluoropyrimidine regimen (5-FU/LV 2-week regimen or capecitabine 3-week regimen).	2	23	4	22	22	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG0030 events0 affected18 at risk EG0040 events0 affected9 at risk EG0051 events1 affected14 at risk EG0060 events0 affected22 at risk EG0070 events0 affected22 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Gallbladder fistula	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Scrotal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Immune-mediated neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0006 events3 affected6 at risk EG0013 events2 affected13 at risk EG0022 events1 affected6 at risk EG0031 events1 affected18 at risk EG0041 events1 affected9 at risk EG0052 events2 affected14 at risk EG0063 events2 affected22 at risk EG0079 events5 affected22 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Myocardial injury	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Myocardial oedema	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Palpitations	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Autoimmune hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0024 events4 affected6 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0016 events5 affected13 at risk EG0025 events3 affected6 at risk EG003
Thyroid disorder	Endocrine disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Dry eye	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Entropion	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Episcleritis	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Eye pain	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Retinopathy	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Trichiasis	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Visual impairment	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Vitreous detachment	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0015 events4 affected13 at risk EG0021 events1 affected6 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0014 events3 affected13 at risk EG0021 events1 affected6 at risk EG003
Dental abfraction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0018 events5 affected13 at risk EG0021 events1 affected6 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Gingival ulceration	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected6 at risk EG0014 events4 affected13 at risk EG00211 events2 affected6 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected6 at risk EG0014 events3 affected13 at risk EG0023 events3 affected6 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0015 events3 affected13 at risk EG0020 events0 affected6 at risk EG003
Asthenia	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0022 events1 affected6 at risk EG003
Catheter site erythema	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Catheter site pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Chest discomfort	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Chills	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0014 events4 affected13 at risk EG0022 events2 affected6 at risk EG003
Generalised oedema	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Influenza like illness	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Localised oedema	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Malaise	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Swelling face	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Temperature intolerance	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Thirst	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Abdominal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Candida infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Nasal vestibulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Paronychia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pericoronitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Periodontitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Rash pustular	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Skin infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Stoma site cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected6 at risk EG0011 events1 affected13 at risk EG0021 events1 affected6 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0006 events4 affected6 at risk EG0012 events2 affected13 at risk EG0025 events3 affected6 at risk EG003
Albumin urine present	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Alpha hydroxybutyrate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Amylase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0022 events1 affected6 at risk EG003
Anti-thyroid antibody increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Apolipoprotein B increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected6 at risk EG0012 events2 affected13 at risk EG0025 events3 affected6 at risk EG003
Bile acids increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood albumin decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected13 at risk EG0025 events2 affected6 at risk EG003
Blood bilirubin unconjugated increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood cholinesterase decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood cholinesterase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood corticotrophin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0022 events1 affected6 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood fibrinogen increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood immunoglobulin E increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood urea increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Blood uric acid increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
C-reactive protein increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Carcinoembryonic antigen increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Electrocardiogram ST segment abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Electrocardiogram high voltage	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Fibrin D dimer increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Gastrointestinal stoma output increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Interleukin level increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Lipase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected6 at risk EG0013 events2 affected13 at risk EG0022 events1 affected6 at risk EG003
Lymphocyte count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Mean cell volume increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected6 at risk EG0011 events1 affected13 at risk EG0024 events2 affected6 at risk EG003
Neutrophil count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Platelet count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected6 at risk EG0010 events0 affected13 at risk EG0027 events2 affected6 at risk EG003
Prealbumin decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Protein total decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Protein urine present	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Thyroxine free decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Thyroxine free increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Tri-iodothyronine free decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Troponin I increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Troponin T increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Urinary occult blood positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Urine bilirubin increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Urobilinogen faeces increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Weight decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0014 events4 affected13 at risk EG0021 events1 affected6 at risk EG003
Weight increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
White blood cell count decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected6 at risk EG0011 events1 affected13 at risk EG0027 events3 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected6 at risk EG0012 events2 affected13 at risk EG0022 events1 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0023 events1 affected6 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected6 at risk EG0011 events1 affected13 at risk EG0023 events2 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0023 events2 affected6 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0005 events2 affected6 at risk EG0010 events0 affected13 at risk EG0022 events1 affected6 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0014 events3 affected13 at risk EG0022 events2 affected6 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events3 affected13 at risk EG0022 events1 affected6 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events3 affected13 at risk EG0021 events1 affected6 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypogeusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Migraine	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Presyncope	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Delusion	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0022 events2 affected6 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Albuminuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0022 events2 affected6 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected13 at risk EG0021 events1 affected6 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Genital discomfort	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Painful ejaculation	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pelvic fluid collection	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Vulval leukoplakia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events3 affected13 at risk EG0021 events1 affected6 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0022 events2 affected6 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pharyngeal swelling	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hair texture abnormal	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0005 events3 affected6 at risk EG0011 events1 affected13 at risk EG0026 events5 affected6 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0014 events2 affected13 at risk EG0021 events1 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0005 events2 affected6 at risk EG0013 events3 affected13 at risk EG0021 events1 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0021 events1 affected6 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003
Hot flush	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0021 events1 affected6 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected13 at risk EG0020 events0 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected13 at risk EG0020 events0 affected6 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected13 at risk EG0020 events0 affected6 at risk EG003

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