A Study of Avastin (Bevacizumab) in Combination With Chem... | NCT00448136

Label	Type	Description	Intervention Names
1	Experimental		Drug: bevacizumab [Avastin] Drug: 5 FU Drug: Streptozotocin
2	Experimental		Drug: bevacizumab [Avastin] Drug: Xeloda

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	7.5mg/kg iv on day 1 every 3 weeks	1 2

Measure	Description	Time Frame
Progression-Free Survival (PFS) - Percentage of Participants With an Event	PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.	Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS - Time to Event	PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.	Screening, every 3 months during treatment, every 6 months during follow-up to 2 years
PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months	PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.

Measure	Description	Time Frame
Percentage of Participants With a Response by Best Overall Response	Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

ID	Title	Description
FG000	Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.

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) - Percentage of Participants With an Event

PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.

ITT population

Posted

Number

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Units	Counts
Participants	OG00034 OG00149

Title

Denominators

Categories

Title	Measurements
	OG00052.9 OG00153.1

Secondary

Percentage of Participants With a Response by Best Overall Response

Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

ITT population. Data were missing from centralized review for 1 participant.

Posted

Number

95% Confidence Interval

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.

Secondary

Duration of Overall Response (OR) - Percentage of Participants With an Event

Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.

ITT population; only participants with a response of CR or PR were included in the analysis.

Posted

Number

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Primary

PFS - Time to Event

PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.

ITT population

Posted

Median

95% Confidence Interval

months

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Primary

PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months

PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.

ITT population

Posted

Number

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Duration of OR - Time to Event

ITT population; only participants with a response of CR or PR were included in the analysis.

Posted

Median

95% Confidence Interval

months

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months

Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.

ITT population

Posted

Number

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event

Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.

ITT population

Posted

Number

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Duration of ODC - Time to Event

Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.

ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.

Posted

Median

95% Confidence Interval

months

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months

Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.

ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.

Posted

Number

percentage of participants

Screening, every 3 months during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Overall Survival (OS) - Percentage of Participants With an Event

OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.

ITT population

Posted

Number

percentage of participants

Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Units	Counts

Secondary

OS - Time to Event

ITT population

Posted

Median

95% Confidence Interval

months

Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Units	Counts

Secondary

OS - Percentage of Participants Surviving at 12 and 24 Months

ITT population.

Posted

Number

percentage of participants

Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Units	Counts

Secondary

Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)

ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Screening, every 3 months during treatment

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Secondary

Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).

ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Number

percentage of participants

Screening, every 3 months during treatment

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.

Secondary

EORTC QLQ-C30 Functional and Symptom Scale Scores

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.

Posted

Mean

Standard Deviation

units on a scale

Screening, every 3 months during treatment

ID	Title	Description
OG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
OG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00024 affected34 at risk EG00124 affected49 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00012 affected34 at risk EG00132 affected49 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00019 affected34 at risk EG0019 affected49 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00013 affected34 at risk EG00112 affected49 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00011 affected34 at risk EG00111 affected49 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00011 affected34 at risk EG0017 affected49 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0015 affected49 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0014 affected49 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0014 affected49 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0005 affected34 at risk EG0012 affected49 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0013 affected49 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0013 affected49 at risk
Flatulence	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0012 affected49 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Toothache	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Loose tooth	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Lip swelling	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Proctitis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Tongue discolouration	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Tongue haematoma	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Asthenia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG00023 affected34 at risk EG00128 affected49 at risk
Mucosal inflammation	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG00014 affected34 at risk EG00117 affected49 at risk
Oedema peripheral	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0019 affected49 at risk
Pyrexia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected34 at risk EG0014 affected49 at risk
Fatigue	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0015 affected49 at risk
Xerosis	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0013 affected49 at risk
Chest pain	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Chills	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0010 affected49 at risk
General physical health deterioration	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Influenza like illness	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0010 affected49 at risk
Malaise	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Oedema	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected49 at risk
Catheter site haematoma	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Catheter site pain	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Drug intolerance	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Face oedema	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Implant site inflammation	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Injection site pain	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Mucosal dryness	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Pain	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Anxiety	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0006 affected34 at risk EG0016 affected49 at risk
Insomnia	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0015 affected49 at risk
Depression	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0013 affected49 at risk
Confusional state	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Sleep disorder	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Stress	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0017 affected49 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0018 affected49 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0016 affected49 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0015 affected49 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0014 affected49 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Erosive balanitis	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Anaphylactic shock	Immune system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Visual acuity reduced	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected49 at risk
Visual impairment	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0015 affected49 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0012 affected49 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0012 affected49 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Dyspnoea extertional	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Weight decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0015 affected49 at risk
Blood bilirubin abnormal	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Blood creatinine decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Blood creatinine increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Cardiac murmur	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Creatinine renal clearance decreased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Gamma-glutamyltransferase abnormal	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Haemoglobin	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Lipase increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0011 affected49 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected49 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Jaundice	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Glycosuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Dysuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected49 at risk
Albuminuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Leukocyturia	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Polyuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0005 affected34 at risk EG0016 affected49 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0014 affected49 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0012 affected49 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0014 affected49 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected34 at risk EG0016 affected49 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0006 affected34 at risk EG0014 affected49 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0013 affected49 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0014 affected49 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0010 affected49 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0012 affected49 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG00013 affected34 at risk EG00114 affected49 at risk
Paraesthesia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0014 affected49 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0014 affected49 at risk
Dysgeusia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0014 affected49 at risk
Dysaesthesia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Migraine	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Sciatica	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Ageusia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Amnesia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Balance disorder	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Burning sensation	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Epilepsy	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Hypokinesia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Loss of consciousness	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Parkinson's disease	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Presyncope	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Sensory disturbance	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Tremor	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected34 at risk EG0014 affected49 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0013 affected49 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0014 affected49 at risk
Pharyngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0014 affected49 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0014 affected49 at risk
Sinusitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0012 affected49 at risk
Tonsillitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0011 affected49 at risk
Cystitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Herpes simplex	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Oral herpes	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0011 affected49 at risk
Tooth abscess	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Injection site infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Rhinitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Tooth infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Candidiasis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Cholecystitis infective	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Chronic sinusitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Erysipelas	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Folliculitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Fungal infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Gastroenteritis escherichia coli	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Hordeolum	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Infected cyst	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Laryngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Oral candidiasis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Post procedural sepsis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Respiratory tract infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Staphylococcal infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Tracheobronchitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Gout	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0012 affected49 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0013 affected49 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0010 affected49 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0010 affected49 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Hyposideraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Conjunctivitis allergic	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Dry eye	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Eyelid oedema	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Vision blurred	Eye disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Flushing	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0019 affected49 at risk
Hot flush	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0011 affected49 at risk
Hypotension	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Haematoma	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Varicose vein	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Vein discolouration	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Venous insufficiency	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Bite	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Burn of internal organs	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Frostbite	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Radiation mucositis	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Cardiac disorder	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Cardiac flutter	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Non-obstructive cardiomyopathy	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Palpitations	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0006 affected34 at risk EG00131 affected49 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0005 affected34 at risk EG0017 affected49 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0018 affected49 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0014 affected49 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected34 at risk EG0011 affected49 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected34 at risk EG0011 affected49 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Hyperkeratosis palmaris and plantaris	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0012 affected49 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0011 affected49 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Dyshidrosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Nail discomfort	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Skin chapped	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected34 at risk EG0010 affected49 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk
Spider naevus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected34 at risk EG0011 affected49 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Angers		49933	France

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
D009607	Nitrosourea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D009603	Nitroso Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description
BG000	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
BG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
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	Bevacizumab + 5-FU + Streptozocin	Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.			11	34	34	34
EG001	Bevacizumab + Capecitabine	Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.			13	49	49	49

ID	Term
D000068258	Bevacizumab
D013311	Streptozocin
D000069287	Capecitabine