A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Comb... | NCT00982657

ID	Type	Description	Link
CVX-060-102	Other Identifier	Alias Study Number
2010-022657-42	EudraCT Number

Label	Type	Description	Intervention Names
Cohort 1	Experimental	CVX-060 + sunitinib	Drug: CVX-060 + sunitinib
Cohort 2	Experimental	CVX-060 + sunitinib	Drug: CVX-060 + sunitinib
Cohort 3	Experimental	CVX-060 + sunitinib	Drug: CVX-060 + sunitinib
Expanded cohort	Experimental	CVX-060 + sunitinib	Drug: CVX-060 + sunitinib
Phase II - Arm A	Experimental	CVX-060 + sunitinib	Drug: CVX-060 + sunitinib
Phase II - Arm B	Active Comparator	sunitinib alone	Drug: Sunitinib

Name	Type	Description	Arm Group Labels	Other Names
CVX-060 + sunitinib	Drug	CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)	Cohort 1

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD)	The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.	Baseline up to Cycle 1( Day 1 to Day 42)
Progression-free Survival (PFS)	PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.	Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)

Measure	Description	Time Frame
Pharmacokinetic Parameters of CVX-060	Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.	Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)

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

Facility	Status	City	State	ZIP	Country	Contacts
Premiere Oncology of Arizona		Scottsdale	Arizona	85258	United States
Premiere Oncology, A Medical Corporation

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

ID	Title	Description
FG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.

ID	Title	Description
BG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
BG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
BG002	CVX-060 12 mg/kg + Sunitinib 50 mg	CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
BG003	CVX-060 15 mg/kg + Sunitinib 50 mg	CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG0013 BG0023 BG00316 BG00434

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

Maximum Tolerated Dose (MTD)

The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.

The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study, no MTD was assessed.

Posted

Baseline up to Cycle 1( Day 1 to Day 42)

ID	Title	Description
OG000	All Participants	All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.

Units	Counts
Participants	OG0000

Primary

Progression-free Survival (PFS)

PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.

The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study.The PFS endpoint was a pre-specified endpoint for the Phase II portion of the study, and was therefore not assessed.

Posted

Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG002	CVX-060 12 mg/kg + Sunitinib 50 mg

Secondary

Pharmacokinetic Parameters of CVX-060

Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.

The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study,pharmacokinetics assessment was not conducted.

Posted

Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.

Secondary

Number of Participants With Dose-limiting Toxicities (DLT)

DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.

Safety Analysis set consisted of all participants who received at least 1 dose of study medication.

Posted

Number

participants

Baseline up to 28 days post last dose of study medication

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.

Secondary

Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels

The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, pharmacodynamics assessment was not conducted.

Posted

Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
OG002	CVX-060 12 mg/kg + Sunitinib 50 mg	CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.

Secondary

Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.

Safety Analysis set consisted of all participants who received at least 1 dose of study medication.

Posted

Number

Participants

Baseline up to 28 days post last dose of study medication

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion.

Secondary

Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.

Safety Analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to 7 days post last dose of study medication

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg

Secondary

Duration of Response

Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.

Duration of response was not calculated as there were no participants with objective response.

Posted

Baseline up to 7 days post last dose of study medication

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG002	CVX-060 12 mg/kg + Sunitinib 50 mg

Secondary

Number of Participants With Anti- CVX-060 Antibodies

The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, no Anti-CVX-060 antibody assessment was conducted.

Posted

Baseline up to 28 days after last CVX-060 dose

ID	Title	Description
OG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
OG002	CVX-060 12 mg/kg + Sunitinib 50 mg	CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG0031 affected16 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0004 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Palpitations	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypogonadism	Endocrine disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0011 affected3 at risk EG0022 affected3 at risk EG003
Cataract	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Diplopia	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Glaucoma	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Photophobia	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Photopsia	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Retinal oedema	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Retinal tear	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Scleral discolouration	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vision blurred	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0004 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0008 affected12 at risk EG0013 affected3 at risk EG0022 affected3 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0006 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0008 affected12 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG003
Oesophageal discomfort	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sensitivity of teeth	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Tongue geographic	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0004 affected12 at risk EG0010 affected3 at risk EG0022 affected3 at risk EG003
Chest discomfort	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chest pain	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chills	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Cyst	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Early satiety	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Face oedema	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Fatigue	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0007 affected12 at risk EG0013 affected3 at risk EG0022 affected3 at risk EG003
Generalised oedema	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Influenza like illness	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Irritability	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Malaise	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Mucosal inflammation	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oedema	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0005 affected12 at risk EG0012 affected3 at risk EG0021 affected3 at risk EG003
Pain	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Temperature intolerance	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Candida infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Conjunctivitis viral	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Eye infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Herpes oesophagitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Influenza	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Rhinitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Tooth infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Anal injury	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
International normalised ratio increased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Occult blood positive	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Weight decreased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
White blood cell count decreased	Investigations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0006 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0005 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0012 affected3 at risk EG0020 affected3 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ataxia	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0005 affected12 at risk EG0010 affected3 at risk EG0022 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hemisensory neglect	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Migraine with aura	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Sciatica	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0003 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Urinary tract pain	Renal and urinary disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Breast discharge	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Genital haemorrhage	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Genital pain	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Genital swelling	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Penile haemorrhage	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Perineal pain	Reproductive system and breast disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0003 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0012 affected3 at risk EG0020 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0012 affected3 at risk EG0020 affected3 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Vocal cord atrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0004 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0002 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0004 affected12 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Facial operation	Surgical and medical procedures	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Flushing	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0011 affected3 at risk EG0020 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0006 affected12 at risk EG0011 affected3 at risk EG0021 affected3 at risk EG003

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CVX-060 6 mg/kg + Sunitinib 50 mg	CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.	4	12	12	12
EG001	CVX-060 6 mg/kg + Sunitinib 37.5 mg	CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.	0	3	3	3
EG002	CVX-060 12 mg/kg + Sunitinib 50 mg	CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.	1	3	3	3
EG003	CVX-060 15 mg/kg + Sunitinib 50 mg	CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.	8	16	16	16

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG0030 affected16 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ileal perforation	Gastrointestinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Disease progression	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Generalised oedema	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0021 affected3 at risk EG003
Herpes oesophagitis	Infections and infestations	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected12 at risk EG0010 affected3 at risk EG0020 affected3 at risk EG003