A Study of Avastin (Bevacizumab) in Combination With Gemc... | NCT01077713

ID	Type	Description	Link
2008-008739-27

Status Module

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

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	7.5mg/kg iv on day 1 of each 3 week cycle	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Alive and Without Progressive Disease at Month 6	Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.	Month 6

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Disease Progression or Death	Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.	Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Rionero in Vulture	Basilicate	85028	Italy

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
BG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Alive and Without Progressive Disease at Month 6

Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.

Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.

Posted

Number

95% Confidence Interval

percentage of participants

Month 6

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Units	Counts
Participants	OG00043 OG00140

Title

Denominators

Categories

Title	Measurements
	OG00025.6(12.5 to 38.6) OG00130.0(15.8 to 44.2)

Secondary

Percentage of Participants With Disease Progression or Death

Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

ITT set

Posted

Number

percentage of participants

Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Secondary

Progression Free Survival (PFS)

PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.

ITT set

Posted

Median

95% Confidence Interval

months

Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Secondary

Percentage of Participants Alive at 12 Months After Randomization

ITT set

Posted

Number

95% Confidence Interval

percentage of participants

1 year

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Units	Counts
Participants

Secondary

Percentage of Participants Who Died

ITT set

Posted

Number

percentage of participants

From randomization to death or end of the study (up to 53 months)

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Units	Counts
Participants

Secondary

Overall Survival (OS)

OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

ITT set

Posted

Median

95% Confidence Interval

months

From randomization to death or end of the study (up to 53 months)

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Units	Counts

Secondary

Percentage of Participants by Best Overall Response

Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

ITT set

Posted

Number

95% Confidence Interval

percentage of participants

Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.

Secondary

Percentage of Participants With an Objective Response

Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

ITT set

Posted

Number

95% Confidence Interval

percentage of participants

Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.

Secondary

Percentage of Participants With Disease Control

Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

ITT set

Posted

Number

95% Confidence Interval

percentage of participants

Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin

Secondary

Duration of Response (DoR)

DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.

ITT set.

Posted

Median

95% Confidence Interval

months

Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)

ID	Title	Description
OG000	Bevacizumab + Gemcitabine	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
OG001	Bevacizumab + Gemcitabine + Cisplatin

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	Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.			17	43	38	43
EG001	Bevacizumab + Gemcitabine + Cisplatin	Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.			10	40	37	40

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Cardiac arrest	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Cardiac failure	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Myocardial infarction	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
General physical health deterioration	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected43 at risk EG0010 affected40 at risk
Pyrexia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Bronchopneumonia	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Pneumonia	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Urinary tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Aphasia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected43 at risk EG0010 affected40 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected43 at risk EG0010 affected40 at risk
Lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Pulmonary Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected43 at risk EG0010 affected40 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected40 at risk
Embolism	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected43 at risk EG0012 affected40 at risk
Hypertension	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk
Thrombosis	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected43 at risk EG00112 affected40 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG00111 affected40 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG00012 affected43 at risk EG00123 affected40 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected43 at risk EG00116 affected40 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected43 at risk EG0018 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected43 at risk EG0015 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0008 affected43 at risk EG00117 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected43 at risk EG0016 affected40 at risk
Asthenia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0009 affected43 at risk EG00110 affected40 at risk
Chest pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected43 at risk EG0012 affected40 at risk
Fatigue	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0008 affected43 at risk EG00115 affected40 at risk
Mucosal inflammation	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0015 affected40 at risk
Pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Pyrexia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0008 affected43 at risk EG0018 affected40 at risk
Tooth abscess	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Blood creatinine increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0014 affected40 at risk
Platelet count decreased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected43 at risk EG0015 affected40 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0013 affected40 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0013 affected40 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected43 at risk EG0014 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected43 at risk EG0010 affected40 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected43 at risk EG0018 affected40 at risk
Paraesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Proteinuria	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected43 at risk EG0010 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected43 at risk EG0016 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected43 at risk EG0017 affected40 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected40 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected43 at risk EG0014 affected40 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0013 affected40 at risk
Embolism	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected43 at risk EG0015 affected40 at risk
Hypertension	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG00011 affected43 at risk EG0019 affected40 at risk

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
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring