A Study of Ramucirumab in Participants With Gastric or Ga... | NCT02539225

ID	Type	Description	Link
I4T-JE-JVCW	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
S-1/Oxaliplatin + Ramucirumab	Experimental	(Part A) Ramucirumab intravenously (IV) on day 1 and day 8 along with S-1 by mouth (PO) on days 1-14 and oxaliplatin IV on day 1 of each 21 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met then move to Part B. (Part B) Ramucirumab IV on day 1 and day 15 along with paclitaxel IV on day 1, 8, and 15 of each 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.	Drug: Ramucirumab Drug: S-1 Drug: Oxaliplatin Drug: Paclitaxel
S-1/Oxaliplatin + Placebo	Active Comparator	(Part A) Placebo IV on day 1 and day 8 along with S-1 PO on days 1-14 and oxaliplatin IV on day 1 of each 21 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met then move to Part B. (Part B) Ramucirumab IV on day 1 and day 15 along with paclitaxel IV on day 1, 8, and 15 of each 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.	Drug: Ramucirumab Drug: Placebo Drug: S-1 Drug: Oxaliplatin Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Ramucirumab	Drug	Administered IV	S-1/Oxaliplatin + Placebo S-1/Oxaliplatin + Ramucirumab

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.	Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)

Measure	Description	Time Frame
Progression-free Survival to the Second Disease Progression (PFS 2)	Progression-free survival 2 (PFS2) is defined as the time from the date of randomization to second disease progression (defined as the date of first tumor assessment observing PD defined by RECIST v.1.1, after the start of second-line therapy using the last tumor assessment before starting the second-line therapy (RAM+PTX) as the baseline assessment), or death of any cause, whichever occurs first. If the second-line therapy was not started, the OS will be substituted for PFS2. If a post-discontinuation therapy was started before observing PD after the start of second-line therapy. PD is defined as 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. PFS2 will be censored at the date of the last adequate tumor assessment on or before staring the post-discontinuation therapy.

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
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Akashi		673-8558

PubMed Identifier	Type	Citation	Retractions
31373648	Derived	Yoshikawa T, Muro K, Shitara K, Oh DY, Kang YK, Chung HC, Kudo T, Chin K, Kadowaki S, Hamamoto Y, Hironaka S, Yoshida K, Yen CJ, Omuro Y, Bai LY, Maeda K, Ozeki A, Yoshikawa R, Kitagawa Y. Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198243. doi: 10.1001/jamanetworkopen.2019.8243.

Label	URL
A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma	View source

ID	Title	Description
FG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 29, 2016	Jul 14, 2018

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)

PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.

All randomized participants who received any quantity of study drug in Part A. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 23; Placebo + S-1 + Oxaliplatin = 19.

Posted

Median

80% Confidence Interval

Months

Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
OG001	Placebo + S-1 + Oxaliplatin	Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Units	Counts
Participants	OG00096 OG00193

Title

Denominators

Categories

Title	Measurements
	OG0006.34(5.65 to 6.93) OG0016.74(5.75 to 7.13)

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		Stratified Log Rank		0.698														Superiority

Secondary

Progression-free Survival to the Second Disease Progression (PFS 2)

Progression-free survival 2 (PFS2) is defined as the time from the date of randomization to second disease progression (defined as the date of first tumor assessment observing PD defined by RECIST v.1.1, after the start of second-line therapy using the last tumor assessment before starting the second-line therapy (RAM+PTX) as the baseline assessment), or death of any cause, whichever occurs first. If the second-line therapy was not started, the OS will be substituted for PFS2. If a post-discontinuation therapy was started before observing PD after the start of second-line therapy. PD is defined as 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. PFS2 will be censored at the date of the last adequate tumor assessment on or before staring the post-discontinuation therapy.

All randomized participants who received any quantity of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 26; Placebo + S-1 + Oxaliplatin = 26.

Posted

Median

80% Confidence Interval

Months

Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months)

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Secondary

Overall Survival (OS)

Overall survival is defined as time from the date of randomization to the date of death from any cause. If the patient was alive at the cut-off for analysis (or lost to follow-up), OS data were censored for analysis on the last date the patient was known to be alive.

All randomized participants who received at least one dose of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 27; Placebo + S-1 + Oxaliplatin = 30.

Posted

Median

80% Confidence Interval

Months

Randomization to Death Due to Any Cause (Up to 31 Months)

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
OG001	Placebo + S-1 + Oxaliplatin	Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Secondary

Percentage of Participants With Objective Response Rate (ORR)

The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR is defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression.

All randomized participants who received any quantity of study drug in Part A with measurable disease.

Posted

Number

80% Confidence Interval

percentage of participants

Randomization to Disease Progression (Up to 25 Months)

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Secondary

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. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression.

All randomized participants who received any quantity of study drug in Part A with measurable disease.

Posted

Number

80% Confidence Interval

percentage of participants

Randomization to Disease Progression (Up to 25 Months)

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Secondary

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A.

All randomized participants who received at least one dose of ramucirumab in part A and had evaluable PK samples.

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram per milliliter (ug/mL)

Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 Predose

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin - Part A	Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B.

All randomized participants who received at least one dose of ramucirumab in part B and had evaluable PK samples.

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram per milliliter (ug/mL)

Cycle 1 Day 1 predose, Cycle 2 Day 1 predose

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin Part B	Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
OG001	Placebo + S-1 + Oxaliplatin - Part B	Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Units	Counts
Participants

Secondary

Number of Participants With Anti-Ramucirumab Antibodies

Participant is considered as treatment emergent anti-drug antibody (TE ADA) positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer >= 20.

All randomized participants who received any quantity of study drug in part A and had at least one baseline & post baseline antibody (ADA) measurement.

Posted

Count of Participants

Participants

Baseline through 25 months

ID	Title	Description
OG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
OG001	Placebo + S-1 + Oxaliplatin	Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG0030 events0 affected64 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0023 events3 affected58 at risk EG003
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0013 events3 affected93 at risk EG0021 events1 affected58 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastric perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0023 events3 affected58 at risk EG003
Gastric stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Ileal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0022 events1 affected58 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Prepyloric stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cholecystocholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Anal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Arthritis infective	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Mycobacterial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0023 events2 affected58 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0022 events1 affected58 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00037 events25 affected96 at risk EG00132 events20 affected93 at risk EG00219 events15 affected58 at risk EG00323 events11 affected64 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0007 events3 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00017 events6 affected96 at risk EG00120 events6 affected93 at risk EG0029 events3 affected58 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00013 events5 affected96 at risk EG0015 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Tachyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected34 at risk EG003
Eustachian tube patulous	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Corneal erosion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dry eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Eye discharge	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0013 events3 affected93 at risk EG0021 events1 affected58 at risk EG003
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0013 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Hyalosis asteroid	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Iridocyclitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0014 events4 affected93 at risk EG0021 events1 affected58 at risk EG003
Ocular hypertension	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Panophthalmitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Scleral haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected96 at risk EG00112 events11 affected93 at risk EG0023 events2 affected58 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00026 events18 affected96 at risk EG00128 events21 affected93 at risk EG0027 events7 affected58 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events9 affected96 at risk EG0016 events6 affected93 at risk EG0021 events1 affected58 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Anal inflammation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected96 at risk EG0016 events6 affected93 at risk EG0022 events2 affected58 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00052 events33 affected96 at risk EG00132 events30 affected93 at risk EG0023 events3 affected58 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0012 events1 affected93 at risk EG0022 events2 affected58 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG000103 events49 affected96 at risk EG00162 events28 affected93 at risk EG00215 events10 affected58 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected96 at risk EG0014 events4 affected93 at risk EG0022 events1 affected58 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0013 events3 affected93 at risk EG0020 events0 affected58 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Gastric fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastric stenosis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0014 events4 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0012 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Lip pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00090 events54 affected96 at risk EG00169 events37 affected93 at risk EG0025 events5 affected58 at risk EG003
Oesophageal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Regurgitation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Salivary gland fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00048 events27 affected96 at risk EG00125 events18 affected93 at risk EG00210 events9 affected58 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Tooth loss	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected96 at risk EG0013 events3 affected93 at risk EG0021 events1 affected58 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00049 events28 affected96 at risk EG00134 events21 affected93 at risk EG0026 events5 affected58 at risk EG003
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Axillary pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Catheter site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0011 events1 affected93 at risk EG0022 events2 affected58 at risk EG003
Face oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0012 events2 affected93 at risk EG0023 events3 affected58 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00035 events28 affected96 at risk EG00135 events22 affected93 at risk EG0028 events7 affected58 at risk EG003
Feeling cold	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Feeling hot	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Impaired healing	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0014 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Infusion site extravasation	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0013 events3 affected93 at risk EG0021 events1 affected58 at risk EG003
Infusion site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Injection site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG00010 events6 affected96 at risk EG00117 events8 affected93 at risk EG0021 events1 affected58 at risk EG003
Injury associated with device	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Localised oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG00035 events26 affected96 at risk EG00125 events20 affected93 at risk EG00211 events9 affected58 at risk EG003
Medical device site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Nodule	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG00031 events26 affected96 at risk EG00124 events19 affected93 at risk EG0028 events8 affected58 at risk EG003
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected96 at risk EG0014 events4 affected93 at risk EG0021 events1 affected58 at risk EG003
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00028 events22 affected96 at risk EG00143 events22 affected93 at risk EG0029 events7 affected58 at risk EG003
Sensation of foreign body	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Tenderness	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0015 events5 affected93 at risk EG0022 events2 affected58 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Actinomycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Anal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Angular cheilitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0015 events2 affected93 at risk EG0023 events1 affected58 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Enterococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Eye infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gingivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Herpes ophthalmic	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0012 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Lip infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0015 events3 affected93 at risk EG0020 events0 affected58 at risk EG003
Mucosal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Mycobacterial infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Nail infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0014 events3 affected93 at risk EG0024 events4 affected58 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Paronychia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Periodontitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0023 events3 affected58 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0022 events2 affected58 at risk EG003
Purulence	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pyoderma	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0013 events3 affected93 at risk EG0020 events0 affected58 at risk EG003
Tinea infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Tracheitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00011 events8 affected96 at risk EG0017 events6 affected93 at risk EG0023 events3 affected58 at risk EG003
Urethritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events3 affected96 at risk EG0016 events3 affected93 at risk EG0022 events2 affected58 at risk EG003
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0013 events3 affected93 at risk EG0022 events2 affected58 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG00113 events6 affected93 at risk EG0021 events1 affected58 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0013 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0006 events1 affected96 at risk EG0014 events3 affected93 at risk EG0020 events0 affected58 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Post procedural discomfort	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Stoma site discharge	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Wound complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Wound secretion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00032 events21 affected96 at risk EG00118 events12 affected93 at risk EG0026 events4 affected58 at risk EG003
Amylase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00045 events25 affected96 at risk EG00126 events15 affected93 at risk EG0027 events5 affected58 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected96 at risk EG0018 events7 affected93 at risk EG0028 events5 affected58 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG00111 events9 affected93 at risk EG0023 events3 affected58 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0005 events3 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Endoscopic retrograde cholangiopancreatography	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected96 at risk EG0015 events5 affected93 at risk EG0022 events2 affected58 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
International normalised ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Lipase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0017 events3 affected93 at risk EG0025 events2 affected58 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG000156 events48 affected96 at risk EG00179 events32 affected93 at risk EG00285 events33 affected58 at risk EG003
Neutrophil count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Peritoneal effluent erythrocyte count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00067 events33 affected96 at risk EG00162 events28 affected93 at risk EG0024 events4 affected58 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00013 events11 affected96 at risk EG00118 events9 affected93 at risk EG0025 events3 affected58 at risk EG003
Weight increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0012 events2 affected93 at risk EG0022 events2 affected58 at risk EG003
White blood cell count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00074 events24 affected96 at risk EG00158 events18 affected93 at risk EG00249 events19 affected58 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00078 events53 affected96 at risk EG00190 events57 affected93 at risk EG0029 events9 affected58 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0014 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00011 events2 affected96 at risk EG00112 events7 affected93 at risk EG0020 events0 affected58 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00011 events6 affected96 at risk EG0015 events3 affected93 at risk EG0023 events3 affected58 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0014 events3 affected93 at risk EG0024 events1 affected58 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00014 events11 affected96 at risk EG00112 events11 affected93 at risk EG00210 events6 affected58 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0006 events3 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0012 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0008 events4 affected96 at risk EG0014 events2 affected93 at risk EG0026 events5 affected58 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0015 events5 affected93 at risk EG0027 events6 affected58 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00013 events6 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected96 at risk EG0019 events7 affected93 at risk EG0023 events3 affected58 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected96 at risk EG00111 events10 affected93 at risk EG0025 events3 affected58 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0022 events1 affected58 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0013 events3 affected93 at risk EG0020 events0 affected58 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0005 events4 affected96 at risk EG0016 events5 affected93 at risk EG0024 events4 affected58 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events6 affected96 at risk EG0015 events4 affected93 at risk EG0021 events1 affected58 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected29 at risk EG0020 events0 affected58 at risk EG003
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0017 events7 affected93 at risk EG0025 events5 affected58 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected29 at risk EG0020 events0 affected58 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected96 at risk EG0017 events6 affected93 at risk EG0022 events2 affected58 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00024 events21 affected96 at risk EG00120 events20 affected93 at risk EG0025 events5 affected58 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00029 events16 affected96 at risk EG00121 events12 affected93 at risk EG0021 events1 affected58 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00013 events7 affected96 at risk EG0014 events4 affected93 at risk EG0023 events3 affected58 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Parosmia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00088 events56 affected96 at risk EG001120 events70 affected93 at risk EG0028 events8 affected58 at risk EG003
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Tremor	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected96 at risk EG00111 events10 affected93 at risk EG0026 events6 affected58 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0014 events3 affected93 at risk EG0021 events1 affected58 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0007 events5 affected96 at risk EG0015 events5 affected93 at risk EG0020 events0 affected58 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG00040 events25 affected96 at risk EG00125 events14 affected93 at risk EG00214 events6 affected58 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0013 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected57 at risk EG0011 events1 affected64 at risk EG0020 events0 affected58 at risk EG003
Oedema genital	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Penile oedema	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Penile pain	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0013 events1 affected29 at risk EG0020 events0 affected58 at risk EG003
Vulvovaginal inflammation	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events7 affected96 at risk EG00112 events10 affected93 at risk EG0023 events3 affected58 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events4 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0013 events3 affected93 at risk EG0022 events2 affected58 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00034 events24 affected96 at risk EG0017 events6 affected93 at risk EG00210 events10 affected58 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events6 affected96 at risk EG0016 events5 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Laryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0013 events2 affected93 at risk EG0021 events1 affected58 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Pleural adhesion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected96 at risk EG00112 events8 affected93 at risk EG0022 events2 affected58 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected96 at risk EG0015 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected96 at risk EG0012 events2 affected93 at risk EG00226 events26 affected58 at risk EG003
Cutaneous symptom	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0014 events4 affected93 at risk EG0021 events1 affected58 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected96 at risk EG0015 events5 affected93 at risk EG0022 events2 affected58 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0023 events3 affected58 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0022 events2 affected58 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00016 events15 affected96 at risk EG0017 events7 affected93 at risk EG0022 events2 affected58 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected96 at risk EG0017 events5 affected93 at risk EG0023 events3 affected58 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG00110 events8 affected93 at risk EG0021 events1 affected58 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0010 events0 affected93 at risk EG0024 events4 affected58 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected96 at risk EG00115 events15 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Abdominal cavity drainage	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0011 events1 affected93 at risk EG0022 events2 affected58 at risk EG003
Bile duct stent insertion	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Cell-free and concentrated ascites reinfusion therapy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Central venous catheterisation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0012 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Cerebrospinal fluid reservoir placement	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Colostomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Gastroenterostomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Gastrointestinal tube insertion	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0014 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Haematoma evacuation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hysterosalpingo-oophorectomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected29 at risk EG0020 events0 affected58 at risk EG003
Ileostomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Laparoscopic surgery	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Laparotomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Limb operation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Nephrostomy	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0021 events1 affected58 at risk EG003
Oesophageal dilation procedure	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Omental flap operation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0022 events2 affected58 at risk EG003
Omental implantation	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Salpingo-oophorectomy bilateral	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected29 at risk EG0020 events0 affected58 at risk EG003
Small intestinal intussusception reduction	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Stent placement	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected96 at risk EG0013 events3 affected93 at risk EG0021 events1 affected58 at risk EG003
Suture insertion	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Thoracic cavity drainage	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0021 events1 affected58 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Tumour excision	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Ureteral stent insertion	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0022 events2 affected58 at risk EG003
Embolism venous	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Flushing	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0013 events2 affected93 at risk EG0020 events0 affected58 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected96 at risk EG0010 events0 affected93 at risk EG0020 events0 affected58 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00028 events28 affected96 at risk EG00113 events12 affected93 at risk EG0021 events1 affected58 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0016 events4 affected93 at risk EG0020 events0 affected58 at risk EG003
Phlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected96 at risk EG0011 events1 affected93 at risk EG0020 events0 affected58 at risk EG003
Vascular pain	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0007 events3 affected96 at risk EG0013 events3 affected93 at risk EG0020 events0 affected58 at risk EG003
Vasculitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected96 at risk EG0018 events4 affected93 at risk EG0020 events0 affected58 at risk EG003

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
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Ramucirumab + S-1 + Oxaliplatin	Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
BG001	Placebo + S-1 + Oxaliplatin	Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met. Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ramucirumab + S-1 + Oxaliplatin - Part A	Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.	2	96	29	96	95	96
EG001	Placebo + S-1 + Oxaliplatin - Part A	Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.	1	93	24	93	93	93
EG002	Ramucirumab + S-1 + Oxaliplatin Part B	Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.	1	58	16	58	58	58
EG003	Placebo + S-1 + Oxaliplatin - Part B	Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.	0	64	14	64	64	64

ID	Term
D000096662	Ramucirumab
C079198	S 1 (combination)
D000077150	Oxaliplatin
D017239	Paclitaxel