A Study of Avastin (Bevacizumab) Added to a Chemotherapeu... | NCT01214720

NCT01214720

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
1	Experimental		Drug: bevacizumab [Avastin]

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	Intervenous repeating dose	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of Overall Survival - Percentage of Participants With an Event	Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.	Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Duration of Overall Survival - Time to Event	Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.	Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized

Secondary Outcomes

Measure	Description	Time Frame
Clinical Benefit Response (CBR)		Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Progression-Free Survival (PFS) - Percentage of Participants With an Event

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg per square meter (mg/m^2) IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, orally (PO), once daily (QD) for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.

Arm/Group Information

ID	Title	Description
BG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.
BG001	Placebo + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00072.2 OG00177.4

Secondary

Clinical Benefit Response (CBR)

The analysis of the CBR was dependent on the calculation of analgesic therapy (AT); this calculation relies on established conversion factors for different morphine derivatives (MD). Many MD utilized by participants do not have well-established conversion factors, yielding uninterpretable results. Therefore, CBR was not analyzed in this study.

Posted

Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized

ID	Title	Description
OG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Placebo + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Secondary

Progression-Free Survival (PFS) - Percentage of Participants With an Event

ITT population.

Posted

Number

percentage of participants

Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression

ID	Title	Description
OG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Secondary

Progression-Free Survival (PFS) - Time to Event

PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method.

ITT Population

Posted

Median

95% Confidence Interval

months

Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression

ID	Title	Description
OG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Placebo + Gemcitabine + Erlotinib

Secondary

Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment

Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits.

ITT Population.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and Week 8

ID	Title	Description
OG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Primary

Duration of Overall Survival - Time to Event

Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.

ITT Population.

Posted

Median

95% Confidence Interval

months

Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized

ID	Title	Description
OG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Placebo + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Secondary

Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib

Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment.

ITT Population. Number (n) = number of participants assessed at a specific visit.

Posted

Geometric Mean

Standard Deviation

micrograms/milliliter

Weeks 1, 3, 5, 7, and 9

ID	Title	Description
OG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bevacizumab + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.			139	297	290	297
EG001	Placebo + Gemcitabine + Erlotinib	Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks. Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.			119	286	276	286

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected297 at risk EG0012 affected286 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected297 at risk EG0014 affected286 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected297 at risk EG0014 affected286 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0014 affected286 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected297 at risk EG0013 affected286 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected297 at risk EG0012 affected286 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected286 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Ileus	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected286 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Ascites	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Melaena	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Sigmoiditis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Subileus	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected297 at risk EG0016 affected286 at risk
Pneumonia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected297 at risk EG0012 affected286 at risk
Abdominal abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0011 affected286 at risk
Bronchitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected286 at risk
Septic Shock	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected286 at risk
Bacterial sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Biliary tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected286 at risk
Escherichia sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected286 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Bacterial infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Biliary sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Cellulitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Central line infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected286 at risk
Disseminated cytomegaloviral infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Diverticulitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Infected insect bite	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Laryngitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Osteomyelitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Pilonidal cyst	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Renal cyst infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Wound infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected297 at risk EG00112 affected286 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected297 at risk EG0013 affected286 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0012 affected286 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0011 affected286 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected286 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pulmonary Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Pyrexia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00016 affected297 at risk EG00111 affected286 at risk
General physical health deterioration	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0013 affected286 at risk
Asthenia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected286 at risk
Oedema peripheral	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected286 at risk
Death	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Oedema	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Sudden death	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected297 at risk EG0013 affected286 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected286 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0011 affected286 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Acquired haemophilia with anti FVIII, XI, or XIII	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected297 at risk EG0015 affected286 at risk
Thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0012 affected286 at risk
Aortic dissection	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Cardiovascular insufficiency	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Haemorrhage	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Venous thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected297 at risk EG0013 affected286 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0013 affected286 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0011 affected286 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0012 affected286 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected297 at risk EG0014 affected286 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0011 affected286 at risk
Jaundice	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected297 at risk EG0010 affected286 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0013 affected286 at risk
Cerebral infarction	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Syncope	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Dizziness	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Lacunar infarction	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Neurological symptom	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected297 at risk EG0011 affected286 at risk
Cardiac failure	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Angina pectoris	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Left ventricular failure	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pericarditis	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Stent occlusion	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0011 affected286 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Hepatic haematoma	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Renal failure	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Renal impairment	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Anuria	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Proteinuria	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Renal colic	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Blood creatinine increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Blood potassium decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
C-reactive protein increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Haemoglobin decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Hepatic enzyme increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected297 at risk EG0010 affected286 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Lymphangiosis carcinomatosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Anxiety	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Depression	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Ileectomy	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected297 at risk EG0014 affected286 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Malabsorption	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected297 at risk EG0011 affected286 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Fatigue	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Perianal abcess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected297 at risk EG0010 affected286 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000145 affected297 at risk EG001144 affected286 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000135 affected297 at risk EG001146 affected286 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000108 affected297 at risk EG001118 affected286 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00079 affected297 at risk EG00165 affected286 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00046 affected297 at risk EG00139 affected286 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00033 affected297 at risk EG00129 affected286 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00034 affected297 at risk EG00119 affected286 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00025 affected297 at risk EG00120 affected286 at risk
Flatulence	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00019 affected297 at risk EG00110 affected286 at risk
Fatigue	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG000104 affected297 at risk EG00197 affected286 at risk
Pyrexia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00094 affected297 at risk EG00199 affected286 at risk
Oedema peripheral	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00051 affected297 at risk EG00149 affected286 at risk
Asthenia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00041 affected297 at risk EG00144 affected286 at risk
Mucosal inflammation	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00025 affected297 at risk EG00129 affected286 at risk
Chills	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00018 affected297 at risk EG00115 affected286 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000146 affected297 at risk EG001126 affected286 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00040 affected297 at risk EG00144 affected286 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00037 affected297 at risk EG00123 affected286 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00030 affected297 at risk EG00117 affected286 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00025 affected297 at risk EG00119 affected286 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00022 affected297 at risk EG00118 affected286 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00077 affected297 at risk EG00196 affected286 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00093 affected297 at risk EG00176 affected286 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00087 affected297 at risk EG00175 affected286 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00016 affected297 at risk EG00120 affected286 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00089 affected297 at risk EG00132 affected286 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00031 affected297 at risk EG00126 affected286 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00024 affected297 at risk EG00124 affected286 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00016 affected297 at risk EG0017 affected286 at risk
Headache	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00039 affected297 at risk EG00124 affected286 at risk
Dysgeusia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00035 affected297 at risk EG00126 affected286 at risk
Dizziness	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00020 affected297 at risk EG00123 affected286 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG00064 affected297 at risk EG00166 affected286 at risk
Insomnia	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG00035 affected297 at risk EG00125 affected286 at risk
Depression	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG00015 affected297 at risk EG00118 affected286 at risk
Anxiety	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG00018 affected297 at risk EG00110 affected286 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG00058 affected297 at risk EG00128 affected286 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00021 affected297 at risk EG00122 affected286 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00020 affected297 at risk EG0019 affected286 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00029 affected297 at risk EG00117 affected286 at risk
Weight decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG00015 affected297 at risk EG00121 affected286 at risk
Proteinuria	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG00015 affected297 at risk EG0014 affected286 at risk

Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.

Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.

Facility	Status	City	State	ZIP	Country	Contacts
		Adelaide		5011	Australia

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

ID	Term
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