Study of Pegilodecakin (LY3500518) With FOLFOX Compared t... | NCT02923921

ID	Type	Description
J1L-AM-JZGB	Other Identifier	Eli Lilly and Company
AM0010-301	Other Identifier	ARMO BioSciences
2016-003858-33	EudraCT Number

Status Module

Name	Class
ARMO BioSciences	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pegilodecakin + FOLFOX	Experimental	Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.	Biological: Pegilodecakin Drug: FOLFOX
FOLFOX	Active Comparator	FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.	Drug: FOLFOX

Name	Type	Description	Arm Group Labels	Other Names
Pegilodecakin	Biological	Pegilodecakin plus FOLFOX	Pegilodecakin + FOLFOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.	Randomization to date of death from any cause (Up To 30 Months)

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival	PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The presence of metastatic pancreatic adenocarcinoma
Measurable disease per RECIST v.1.1
Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
Eastern Cooperative Oncology Group Performance Status of 0 - 1
Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
No peripheral neuropathy
No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria:

Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
Participants who were intolerant of a gemcitabine containing regimen.
History of positivity for human immunodeficiency virus
Chronic active or active viral hepatitis A, B, or C infection
Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
Pregnant or lactating women
Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period
Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center		Gilbert	Arizona	85234	United States
Cancer Treatment Centers of America

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33555926	Derived	Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing less than or equal to (≤) 80 kg or 0.8 mg for participants weighing greater than (>) 80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 5, 2018	Aug 10, 2020

Arm/Group Information

ID	Title	Description
BG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
BG001	FOLFOX	FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.8± 9.0 BG00164.1± 9.9 BG00264.0± 9.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000135 BG001132 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00093 BG00189 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival

Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.

All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 63 and FOLFOX = 73.

Posted

Median

95% Confidence Interval

Months

Randomization to date of death from any cause (Up To 30 Months)

ID	Title	Description
OG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
OG001	FOLFOX	FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.

Units	Counts
Participants	OG000283 OG001284

Title

Denominators

Categories

Title	Measurements
	OG0005.78(5.45 to 6.64) OG0016.28(5.62 to 7.39)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).	Log Rank		0.6565		Hazard Ratio (HR)	1.045			2-Sided	95	0.863	1.265					Superiority

Secondary

Progression Free Survival

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.

All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 45 and FOLFOX = 86.

Posted

Median

95% Confidence Interval

Months

Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

ID	Title	Description
OG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.

Secondary

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.

All randomized participants.

Posted

Number

Percentage of participants

Randomization to PD (Up To 30 Months)

ID	Title	Description
OG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.

Secondary

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

All randomized participants.

Posted

Number

Percentage of participants

Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)

ID	Title	Description
OG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.

Secondary

Duration of Response (DOR)

DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

All randomized participants who achieved an objective response of CR or PR. The number of participants censored were Pegilodecakin + FOLFOX = 4 and FOLFOX = 7.

Posted

Median

95% Confidence Interval

Months

Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

ID	Title	Description
OG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.

Secondary

Percentage of Participants Alive at 1 Year (12-Month Survival Rate)

The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.

All randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization to until the date of first documented date of death from any cause within 12 months

ID	Title	Description
OG000	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.
OG001	FOLFOX	FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.

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	Pegilodecakin + FOLFOX	Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX [dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression [that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing>80 kg.	217	278	123	278	271	278
EG001	FOLFOX	FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.	188	251	95	251	240	251

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0005 events3 affected278 at risk EG0012 events1 affected251 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected251 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0014 events3 affected251 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected251 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected251 at risk
Cardiac arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected251 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00014 events11 affected278 at risk EG0013 events3 affected251 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0015 events5 affected251 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Gastrointestinal stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected251 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0013 events3 affected251 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected278 at risk EG0010 events0 affected251 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0012 events2 affected251 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected278 at risk EG0015 events5 affected251 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Euthanasia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected278 at risk EG0012 events2 affected251 at risk
General physical health deterioration	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0013 events2 affected251 at risk
Generalised oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hyperpyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Mucosal inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00015 events13 affected278 at risk EG0017 events7 affected251 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0008 events6 affected278 at risk EG0012 events2 affected251 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected251 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0013 events3 affected251 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Abdominal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected251 at risk
Bacterial disease carrier	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Biliary sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0012 events2 affected251 at risk
Biliary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0014 events1 affected251 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected278 at risk EG0010 events0 affected251 at risk
Cholangitis infective	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected251 at risk
Device related infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected278 at risk EG0010 events0 affected251 at risk
Device related sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Enterobacter sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Escherichia sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Liver abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected278 at risk EG0014 events4 affected251 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00010 events10 affected278 at risk EG0014 events4 affected251 at risk
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 events4 affected278 at risk EG0010 events0 affected251 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Urosepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected278 at risk EG0016 events4 affected251 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected278 at risk EG0010 events0 affected251 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0011 events1 affected251 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0013 events3 affected251 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected278 at risk EG0011 events1 affected251 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected251 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Sciatica	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Device breakage	Product Issues	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Device failure	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Device occlusion	Product Issues	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected278 at risk EG0010 events0 affected251 at risk
Completed suicide	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Mental status changes	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Suicide attempt	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Oliguria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected144 at risk EG0010 events0 affected134 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0011 events1 affected251 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0010 events0 affected251 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0013 events3 affected251 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Aortic embolus	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected278 at risk EG0011 events1 affected251 at risk
Embolism	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected278 at risk EG0012 events2 affected251 at risk
Internal haemorrhage	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected251 at risk
Peripheral coldness	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected278 at risk EG0011 events1 affected251 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG000204 events107 affected278 at risk EG00156 events38 affected251 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG000118 events58 affected278 at risk EG00165 events41 affected251 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG000296 events99 affected278 at risk EG00142 events28 affected251 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00022 events18 affected278 at risk EG00115 events14 affected251 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000114 events82 affected278 at risk EG00182 events58 affected251 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00034 events20 affected278 at risk EG00117 events14 affected251 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00035 events28 affected278 at risk EG00120 events19 affected251 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00093 events79 affected278 at risk EG00170 events59 affected251 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000104 events70 affected278 at risk EG001101 events71 affected251 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00023 events21 affected278 at risk EG00116 events14 affected251 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00015 events14 affected278 at risk EG0016 events4 affected251 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000217 events126 affected278 at risk EG001160 events106 affected251 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00037 events27 affected278 at risk EG00148 events40 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000122 events80 affected278 at risk EG001106 events69 affected251 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG000151 events76 affected278 at risk EG001105 events45 affected251 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG000181 events105 affected278 at risk EG001108 events74 affected251 at risk
Injection site erythema	General disorders	MedDRA 23.0	Systematic Assessment	EG00018 events18 affected278 at risk EG0010 events0 affected251 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG00049 events41 affected278 at risk EG00125 events22 affected251 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00082 events56 affected278 at risk EG00151 events36 affected251 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00017 events12 affected278 at risk EG00122 events14 affected251 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00028 events21 affected278 at risk EG00120 events15 affected251 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00028 events19 affected278 at risk EG00112 events10 affected251 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00084 events47 affected278 at risk EG00151 events30 affected251 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG000163 events59 affected278 at risk EG00151 events26 affected251 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00017 events14 affected278 at risk EG00134 events25 affected251 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG000132 events97 affected278 at risk EG001100 events77 affected251 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00022 events12 affected278 at risk EG00119 events14 affected251 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00020 events14 affected278 at risk EG00111 events10 affected251 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00028 events20 affected278 at risk EG00111 events10 affected251 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00037 events21 affected278 at risk EG00139 events29 affected251 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00015 events11 affected278 at risk EG00121 events16 affected251 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00044 events37 affected278 at risk EG00139 events32 affected251 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00023 events19 affected278 at risk EG0019 events8 affected251 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00022 events19 affected278 at risk EG00111 events9 affected251 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00024 events18 affected278 at risk EG00120 events17 affected251 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00050 events40 affected278 at risk EG00162 events38 affected251 at risk
Neurotoxicity	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00025 events13 affected278 at risk EG00130 events15 affected251 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00034 events24 affected278 at risk EG00144 events17 affected251 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00048 events31 affected278 at risk EG00135 events29 affected251 at risk
Polyneuropathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00013 events9 affected278 at risk EG00125 events14 affected251 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00014 events14 affected278 at risk EG00113 events13 affected251 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00022 events17 affected278 at risk EG00122 events19 affected251 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00041 events30 affected278 at risk EG00117 events15 affected251 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00024 events15 affected278 at risk EG00111 events8 affected251 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00034 events23 affected278 at risk EG00110 events9 affected251 at risk

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
C000632591	pegilodecakin
C000622455	AM0010
C410216	Folfox protocol
D000077150	Oxaliplatin
D005472	Fluorouracil
D002955	Leucovorin

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes