A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bev... | NCT00615056

NCT00615056

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Active Comparator	Bevacizumab (avastin)	Drug: Bevacizumab (avastin) Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
C	Experimental	AG-013736 (axitinib)	Drug: AG-013736 (axitinib) Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
A	Experimental	AG-013736 (axitinib)	Drug: AG-013736 (axitinib) Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])
D	Active Comparator	bevacizumab (avastin)	Drug: Bevacizumab (avastin) Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab (avastin)	Drug	Bevacizumab intravenous [IV] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.	B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").	Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).	Baseline until death or up to 1 year after the randomization of last participant

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Mobile	Alabama	36608	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
BG001	Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
BG002	Axitinib + FOLFOX	Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
BG003	Bevacizumab + FOLFOX	Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks

ID	Title	Description
OG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
OG001	Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
OG002	Axitinib + FOLFOX	Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
OG003	Bevacizumab + FOLFOX	Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Units	Counts
Participants	OG00049 OG00151 OG00236 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005.72(4.50 to 7.42) OG0016.87(4.96 to 9.13) OG0027.59(5.62 to 11.07) OG003

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	Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).	Log Rank		0.8268	One-sided log-rank test at alpha = 0.15 significance level was used.	Hazard Ratio (HR)	1.273			2-Sided	95	0.769	2.108				No	Superiority or Other

Secondary

Overall Survival (OS)

Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.

Posted

Median

95% Confidence Interval

Months

Baseline until death or up to 1 year after the randomization of last participant

ID	Title	Description
OG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
OG001	Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Secondary

Percentage of Participants With Objective Response (OR)

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks

ID	Title	Description
OG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Secondary

Duration of Response (DR)

Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks

ID	Title	Description
OG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
OG001	Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Secondary

Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal

Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.

ITT population. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' is number of participants analyzed at specific time point for each treatment arm respectively.

Posted

Mean

95% Confidence Interval

Units on a Scale

Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal

ID	Title	Description
OG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Secondary

Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal

Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.

Posted

Mean

95% Confidence Interval

Units on a Scale

Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal

ID	Title	Description
OG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.	17	46	45	46
EG001	Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.	9	51	51	51
EG002	Axitinib + FOLFOX	Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.	11	36	35	36
EG003	Bevacizumab + FOLFOX	Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.	5	35	33	35

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG0030 affected35 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Otosalpingitis	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Colonic obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Ileal ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Rectal perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Anal inflammation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Haemorrhagic ascites	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Performance status decreased	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
General physical health deterioration	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Disease progression	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hepatic mass	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Cellulitis pharyngeal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Anal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Lung infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0006 affected46 at risk EG00111 affected51 at risk EG0024 affected36 at risk EG0035 affected35 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0006 affected46 at risk EG0016 affected51 at risk EG0025 affected36 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG00020 affected46 at risk EG00127 affected51 at risk EG00220 affected36 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0014 affected51 at risk EG0028 affected36 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Ear disorder	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
External ear inflammation	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Hyperacusis	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Otosalpingitis	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG0010 affected51 at risk EG0029 affected36 at risk EG003
Age-related macular degeneration	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Asthenopia	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Cataract	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Conjunctival oedema	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Dry eye	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Eye discharge	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Eye irritation	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Eye pain	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Eye pruritus	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Lacrimation increased	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Mydriasis	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Vision blurred	Eye disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Visual impairment	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00012 affected46 at risk EG00111 affected51 at risk EG0027 affected36 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0005 affected46 at risk EG0016 affected51 at risk EG0020 affected36 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Anal inflammation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Anorectal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Chapped lips	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG00116 affected51 at risk EG0023 affected36 at risk EG003
Defaecation urgency	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Dental discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00032 affected46 at risk EG00125 affected51 at risk EG00215 affected36 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG0015 affected51 at risk EG0021 affected36 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Hernial eventration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Lip ulceration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00027 affected46 at risk EG00130 affected51 at risk EG00218 affected36 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0022 affected36 at risk EG003
Painful defaecation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Periodontitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Peristalsis visible	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0006 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Rectal fissure	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Rectal tenesmus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00011 affected46 at risk EG0017 affected51 at risk EG0029 affected36 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Tooth erosion	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00022 affected46 at risk EG00118 affected51 at risk EG00212 affected36 at risk EG003
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG00013 affected46 at risk EG00111 affected51 at risk EG0026 affected36 at risk EG003
Chest discomfort	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0013 affected51 at risk EG0021 affected36 at risk EG003
Chills	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0022 affected36 at risk EG003
Device occlusion	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG00021 affected46 at risk EG00118 affected51 at risk EG00212 affected36 at risk EG003
Implant site haematoma	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Influenza like illness	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Infusion site extravasation	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Injection site reaction	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Mucosal dryness	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Mucosal inflammation	General disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG00111 affected51 at risk EG0024 affected36 at risk EG003
Oedema	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Oedema peripheral	General disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Pain	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0023 affected36 at risk EG003
Performance status decreased	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0005 affected46 at risk EG0017 affected51 at risk EG0025 affected36 at risk EG003
Temperature intolerance	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Thrombosis in device	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Hyperplastic cholecystopathy	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0025 affected36 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Anal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Clostridial infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Colostomy infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Cystitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Device related infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Ear infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Herpes simplex	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Herpes zoster	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hordeolum	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Infected sebaceous cyst	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Laryngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Lung infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0015 affected51 at risk EG0020 affected36 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Oral herpes	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Septic shock	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Tooth abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0013 affected51 at risk EG0022 affected36 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Anal injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Scapula fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Alanine aminotransferase	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Aspartate aminotransferase	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0012 affected51 at risk EG0021 affected36 at risk EG003
Blood albumin decreased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Blood alkaline phosphatase	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood bilirubin	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood bilirubin increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood cholesterol increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood creatine increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood creatinine	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood glucose increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood potassium decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood pressure increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Blood triglycerides increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Breath sounds abnormal	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Carcinoembryonic antigen increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Clostridium test positive	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
General physical condition normal	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Haemoglobin	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Haemoglobin decreased	Investigations	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0015 affected51 at risk EG0023 affected36 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Neutrophil count	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Neutrophil count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0013 affected51 at risk EG0023 affected36 at risk EG003
Platelet count	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Platelet count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0012 affected51 at risk EG0024 affected36 at risk EG003
Visual field tests	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Weight decreased	Investigations	MedDRA	Non-systematic Assessment	EG00013 affected46 at risk EG0014 affected51 at risk EG0025 affected36 at risk EG003
Weight increased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
White blood cell count	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
White blood cell count decreased	Investigations	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
White blood cell count increased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG00024 affected46 at risk EG00116 affected51 at risk EG00213 affected36 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0022 affected36 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0013 affected51 at risk EG0023 affected36 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0022 affected36 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0016 affected51 at risk EG0022 affected36 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0013 affected51 at risk EG0020 affected36 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0013 affected51 at risk EG0021 affected36 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0004 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Ageusia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Aphasia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Cholinergic syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Dizziness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0013 affected51 at risk EG0023 affected36 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0005 affected46 at risk EG0011 affected51 at risk EG0023 affected36 at risk EG003
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0006 affected46 at risk EG0014 affected51 at risk EG0027 affected36 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Myelopathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0014 affected51 at risk EG0027 affected36 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0024 affected36 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0014 affected51 at risk EG0024 affected36 at risk EG003
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Syncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Toxic neuropathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Agitation	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Anxiety	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0013 affected51 at risk EG0021 affected36 at risk EG003
Confusional state	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Delirium	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0005 affected46 at risk EG0013 affected51 at risk EG0022 affected36 at risk EG003
Disorientation	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0012 affected51 at risk EG0022 affected36 at risk EG003
Mood altered	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Nervousness	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0023 affected36 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0008 affected46 at risk EG0015 affected51 at risk EG0022 affected36 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Epididymitis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0007 affected46 at risk EG0015 affected51 at risk EG0023 affected36 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0006 affected46 at risk EG0012 affected51 at risk EG0024 affected36 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0008 affected46 at risk EG0013 affected51 at risk EG0024 affected36 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00011 affected46 at risk EG00115 affected51 at risk EG0024 affected36 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0015 affected51 at risk EG0021 affected36 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0006 affected46 at risk EG00112 affected51 at risk EG0022 affected36 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Facial wasting	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0021 affected36 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0008 affected46 at risk EG0013 affected51 at risk EG0024 affected36 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0012 affected51 at risk EG0024 affected36 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0005 affected46 at risk EG0012 affected51 at risk EG0023 affected36 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Embolism	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Embolism venous	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0011 affected51 at risk EG0020 affected36 at risk EG003
Flushing	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Haematoma	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Haemorrhage	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG00017 affected46 at risk EG0018 affected51 at risk EG00224 affected36 at risk EG003
Hypotension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0003 affected46 at risk EG0011 affected51 at risk EG0022 affected36 at risk EG003
Pallor	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0021 affected36 at risk EG003
Phlebitis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0012 affected51 at risk EG0020 affected36 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003
Vasculitis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected46 at risk EG0010 affected51 at risk EG0020 affected36 at risk EG003

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D002166	Camptothecin
D000470	Alkaloids
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
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D007191	Indazoles
D011720	Pyrazoles
D001393	Azoles
D056831	Coordination Complexes

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

ID	Term
D000068258	Bevacizumab
D000077146	Irinotecan
D002955	Leucovorin
D005472	Fluorouracil
D000077784	Axitinib
C410216	Folfox protocol
D000077150	Oxaliplatin