A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to... | NCT02795988

Label	Type	Description	Intervention Names
Phase 1b	Experimental	10, 30, 50μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine	Biological: IMU-131 Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
Phase 2 - IMU 131 plus chemotherapy	Experimental	50 μg IMU-131 plus Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine.	Biological: IMU-131 Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.
Phase 2 - Chemotherapy only	Experimental	Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and Capecitabine.	Drug: Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.

Name	Type	Description	Arm Group Labels	Other Names
IMU-131	Biological	IMU-131 vaccine is a P467-CRM197 peptide antigen in PBS buffer and Montanide ISA 51 Sterile adjuvant	Phase 1b Phase 2 - IMU 131 plus chemotherapy

Measure	Description	Time Frame
Phase 1b: Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.	Up to approximately 7 months
Phase 2: Overall Survival (OS)	OS was measured from date of randomization to date of death due to any cause.	Up to approximately 30 months
Phase 2 Extension: Number of Participants With AEs	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.	From date of first dose to date of last dose plus 30 days (Up to 24 months)

Measure	Description	Time Frame
Phase 2 and Phase 2 Extension: Progression-Free Survival (PFS)	PFS was measured from randomization to date of earliest progressive disease (PD) based on blinded central review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or to date of death from any cause.	Up to approximately 30 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines;
Age ≥ 20 years old;
Life expectancy of at least 12 weeks;
Phase 1b: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 6 months prior to Day 0; Phase 2: No prior chemotherapy or radiotherapy for advanced gastric or GEJ cancer within 3 months prior to Day 0;
Metastatic gastric or GEJ adenocarcinoma, or locally advanced disease not amenable to surgical resection;
HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization [FISH] or chromogenic in situ hybridization [CISH]). Patients with IHC 2+ expression without confirmation of overexpression by fluorescent in situ hybridization [FISH] or chromogenic in situ hybridization [CISH]) may be included in Phase 1b with agreement of Imugene Limited;
Phase 1b: ECOG performance status 0-1; Phase 2: ECOG performance status 0-2;
At least one measurable lesion as defined by RECIST 1.1 criteria. Patients with non-measurable lesions may be included in Phase1b with agreement of Imugene Limited;
Adequate left ventricular ejection function at baseline, defined as LVEF > 50% by echocardiogram or MUGA scan (Multi Gated Acquisition Scan);
Adequate hematologic function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL;
Adequate liver function evidenced by bilirubin ≤ 1.5 x laboratory upper limit of normal [ULN], and ALT and AST ≤ 3 x laboratory ULN if no liver involvement or ALT and AST ≤ 5 times laboratory ULN with liver involvement;
Adequate renal function (creatinine ≤ 1.5 x laboratory ULN);
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment (see section 4.3 for details). A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

Exclusion Criteria:

Previous treatment with trastuzumab or any other HER2/neu targeting antibody or agent;
Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease;
Prior organ transplant;
Phase 1b: Patient not considered a candidate for 5-FU, capecitabine, or cisplatin chemotherapy; Phase 2: Patient not considered a candidate for 5-FU, capecitabine, cisplatin or oxaliplatin chemotherapy;
History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias; or New York Heart Association (NYHA) class II heart disease;
If on warfarin (Coumadin®) or other vitamin K antagonists;
Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin;
Peripheral neuropathy or hearing loss of NCI CTCAE Grade > 2;
History of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent, participation in the study, or adversely affecting compliance to study drugs;
Active infection requiring IV antibiotics;
Positive for human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or active hepatitis B (HBsAg reactive) or active hepatitis C (HCV ribonucleic acid [RNA] qualitative) infection;
Pregnant or lactating females;
Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic biopsy) within 1 week prior to study entry;
Has received a live-virus vaccination within 4 weeks of first study vaccination. Seasonal flu vaccines that do not contain live virus are permitted;
Current or recent (within 4 weeks of first IMU-131 vaccination) treatment with another investigational drug or participation in another investigational study.
Phase 2: Patients with a known diphtheria toxoid hypersensitivity.

Facility	Status	City	State	ZIP	Country	Contacts
ARENSIA Exploratory Medicine LLC		Tbilisi		0112	Georgia
City Cancer Center

PubMed Identifier	Type	Citation	Retractions
39028916	Derived	Tobias J, Maglakelidze M, Andric Z, Ryspayeva D, Bulat I, Nikolic I, Petrovic Z, Chawla T, Nagarkar R, Garner-Spitzer E, Zielinski CC, Chong LMO, Nixon B, Ede NJ, Yavrom S, Kundi M, Wiedermann U. Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON). Clin Cancer Res. 2024 Sep 13;30(18):4044-4054. doi: 10.1158/1078-0432.CCR-24-0742.
33879458

Label	URL
Imugene (ASX: IMU) is a publicly-listed biotechnology company.	View source

ID	Title	Description
FG000	Phase 1b: 10 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in intramuscular (IM) injections at a single dose level of 10 micrograms (μg) on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included intravenous (IV) cisplatin and either Fluorouracil (5-FU) infusion or oral capecitabine.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 12, 2023	Mar 19, 2025

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Description

Population Description

Reporting Status

Anticipated Posting Date

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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 Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.

The Safety population included all randomized participants who received any amount of study treatment.

Posted

Count of Participants

Participants

Up to approximately 7 months

ID	Title	Description
OG000	Phase 1b: 10 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
OG001	Phase 1b: 30 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
OG002	Phase 1b: 50 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.

Units	Counts
Participants	OG0003 OG0016 OG0025

Title

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Title	Measurements
	OG0003 OG0016 OG0025

Primary

Phase 2: Overall Survival (OS)

OS was measured from date of randomization to date of death due to any cause.

The Intent-to-Treat population included all randomized participants.

Posted

Median

80% Confidence Interval

months

Up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.

Units	Counts
Participants

Primary

Phase 2 Extension: Number of Participants With AEs

The Safety population included all randomized participants who received any amount of study treatment.

Posted

Count of Participants

Participants

From date of first dose to date of last dose plus 30 days (Up to 24 months)

ID	Title	Description
OG000	Phase 2 Extension: IMU-131 100 μg	Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2 Extension: IMU-131 200 μg	Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.

Secondary

Phase 2 and Phase 2 Extension: Progression-Free Survival (PFS)

PFS was measured from randomization to date of earliest progressive disease (PD) based on blinded central review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or to date of death from any cause.

The ITT Population included all randomized participants.

Posted

Median

80% Confidence Interval

months

Up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG002	Phase 2 Extension: IMU-131 100 μg

Secondary

Phase 2 and Phase 2 Extension: Time to Progression (TTP)

TTP was measured from randomization to date of earliest PD based on blinded central review according to RECIST 1.1 criteria.

The ITT Population included all randomized participants.

Posted

Median

80% Confidence Interval

months

Up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG002	Phase 2 Extension: IMU-131 100 μg	Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.

Secondary

Phase 2 and Phase 2 Extension: Disease Control Rate (DCR)

DCR was defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or stable disease according to RECIST 1.1 after randomization/enrollment date.

The Full Analysis Set (FAS) included all randomized participants who received any amount of study treatment.

Posted

Number

80% Confidence Interval

percentage of participants

Up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG002	Phase 2 Extension: IMU-131 100 μg

Secondary

Phase 2 and Phase 2 Extension: Objective Response Rate (ORR)

ORR was defined as the proportion of participants with a BOR of CR or PR according RECIST 1.1 after randomization/enrollment date.

The FAS included all randomized participants who received any amount of study treatment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Number

80% Confidence Interval

percentage of participants

Up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG002	Phase 2 Extension: IMU-131 100 μg

Secondary

Phase 2 and Phase 2 Extension: Duration of Response (DOR)

DOR was defined as the time from the earliest date when a tumor response of CR or PR was observed until the date of first occurrence of disease progression which assessed by the blinded central reviewer or death (due to any reason).

All randomized participants with a BOR of CR or PR

Posted

Median

80% Confidence Interval

months

Up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG002	Phase 2 Extension: IMU-131 100 μg

Secondary

Phase 2 and Phase 2 Extension: Percentage Change From Baseline in Tumor Size

Change in tumor size (CTS) was measured as the sum of diameters based on blinded central review according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

The ITT Population included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Posted

Median

80% Confidence Interval

percentage change from baseline

Baseline up to approximately 30 months

ID	Title	Description
OG000	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG002	Phase 2 Extension: IMU-131 100 μg

Secondary

Phase 2 Extension: OS

OS was measured from date of randomization to date of death due to any cause.

The FAS included all randomized participants who received any amount of study treatment.

Posted

Median

80% Confidence Interval

months

Up to 24 months

ID	Title	Description
OG000	Phase 2 Extension: IMU-131 100 μg	Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
OG001	Phase 2 Extension: IMU-131 200 μg	Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.

Units	Counts

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: 10 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.	1	3	2	3	3	3
EG001	Phase 1b: 30 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.	2	6	4	6	6	6
EG002	Phase 1b: 50 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.	1	5	3	5	5	5
EG003	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.	17	19	2	19	18	19
EG004	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.	17	17	5	17	15	17
EG005	Phase 2 Extension: IMU-131 100 μg	Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.	5	7	0	7	7	7
EG006	Phase 2 Extension: IMU-131 200 μg	Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.	6	7	2	7	5	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG0030 affected19 at risk EG0041 affected17 at risk EG0050 affected7 at risk EG0060 affected7 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected5 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0020 affected5 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Corona virus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected3 at risk EG0015 affected6 at risk EG0020 affected5 at risk EG0033 affected19 at risk EG0045 affected17 at risk EG0052 affected7 at risk EG0060 affected7 at risk
Anaemia folate deficiency	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected6 at risk EG0021 affected5 at risk EG003
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Eye swelling	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected6 at risk EG0020 affected5 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected3 at risk EG0010 affected6 at risk EG0022 affected5 at risk EG003
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Lip ulceration	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected6 at risk EG0023 affected5 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0021 affected5 at risk EG003
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected6 at risk EG0021 affected5 at risk EG003
Mucosal inflammation	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected5 at risk EG003
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected6 at risk EG0021 affected5 at risk EG003
Alcoholic liver disease	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hepatic fibrosis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Administration site infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0022 affected5 at risk EG003
Blood urea increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Liver function test increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0021 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Protein total increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0012 affected6 at risk EG0020 affected5 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected6 at risk EG0022 affected5 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected3 at risk EG0014 affected6 at risk EG0020 affected5 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0013 affected6 at risk EG0021 affected5 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0022 affected5 at risk EG003
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Delirium	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0022 affected5 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0021 affected5 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0012 affected6 at risk EG0020 affected5 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0021 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0011 affected6 at risk EG0020 affected5 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Injection site reaction	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Peripheral swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Extravasation	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Feeling abnormal	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Vaccination site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Chills	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Sciatica	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Cystitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Skin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Embolism	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Eye pain	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
White blood cell count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Peroneal nerve palsy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003
Infusion site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected3 at risk EG0010 affected6 at risk EG0020 affected5 at risk EG003

ID	Term
D005770	Gastrointestinal Neoplasms
D000230	Adenocarcinoma
D009362	Neoplasm Metastasis

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description
BG000	Phase 1b: 10 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
BG001	Phase 1b: 30 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine
BG002	Phase 1b: 50 μg IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
BG003	Phase 2: IMU-131 Plus Chemotherapy	Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
BG004	Phase 2: Chemotherapy Only	Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
BG005	Phase 2 Extension: IMU-131 100 μg	Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
BG006	Phase 2 Extension: IMU-131 200 μg	Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments: IV cisplatin and either 5-FU infusion or oral capecitabine. IV oxaliplatin and oral capecitabine.
BG007	Total	Total of all reporting groups

ID	Term
D002945	Cisplatin
D005472	Fluorouracil
D000069287	Capecitabine
D000077150	Oxaliplatin