AG-013736 In Combination With Docetaxel Versus Docetaxel... | NCT00076024

Label	Type	Description	Intervention Names
Docetaxel + Placebo	Other	Docetaxel + Placebo	Drug: Placebo Drug: Docetaxel
Docetaxel + AG-013736	Experimental	Docetaxel + AG-013736	Drug: AG-013736 (axitinib) Drug: Docetaxel

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	5 mg twice daily [bid] continuous dosing	Docetaxel + Placebo

Measure	Description	Time Frame
Time to Tumor Progression (TTP)	Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).	Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks

Measure	Description	Time Frame
Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)	Percentage of participants with OR 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. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Measure	Description	Time Frame
Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)	Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Tucson	Arizona	85724-5024	United States
Pfizer Investigational Site

ID	Title	Description
FG000	Axitinib + Docetaxel (Phase-1, Lead-in)	Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
FG001

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

Time to Tumor Progression (TTP)

Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.

Posted

Median

95% Confidence Interval

days

Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks

ID	Title	Description
OG000	Axitinib + Docetaxel (Phase 2, Double-blind)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
OG001	Docetaxel + Placebo (Phase 2, Double-blind)	Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.

Units	Counts
Participants	OG000112 OG00155

Title

Denominators

Categories

Title	Measurements
	OG000247(208 to 265) OG001215(191 to 247)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to [=<1] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.	Log Rank	One-sided log-rank test at alpha = 0.1 significance level was used.	0.156		Hazard Ratio (HR)	1.237			2-Sided	95	0.819	1.867				No	Superiority or Other

Secondary

Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)

Percentage of participants with OR 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. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.

Posted

Number

95% Confidence Interval

percentage of participants

Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks

ID	Title	Description
OG000	Axitinib + Docetaxel (Phase 2, Double-blind)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
OG001	Docetaxel + Placebo (Phase 2, Double-blind)

Secondary

Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)

Percentage of participants with OR 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. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

All treated (AT) population included participants from Phase 2 who progressed by RECIST criteria while in the placebo + docetaxel treatment group and had a baseline disease assessment and received at least 1 dose of study medication.

Posted

Number

95% Confidence Interval

percentage of participants

Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks

ID	Title	Description
OG000	Axitinib (Phase 2, Open-label)	Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.

Units	Counts
Participants

Secondary

Duration of Response (DR) for Phase 2 (Double-blind)

Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).

Posted

Median

95% Confidence Interval

days

Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks

ID	Title	Description
OG000	Axitinib + Docetaxel (Phase 2, Double-blind)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
OG001	Docetaxel + Placebo (Phase 2, Double-blind)	Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.

Secondary

Duration of Response (DR) for Phase 2 (Open-label)

Subgroup of participants from the AT population with a confirmed objective tumor response (CR or PR).

Posted

Median

95% Confidence Interval

days

Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks

ID	Title	Description
OG000	Axitinib (Phase 2, Open-label)	Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Not Posted

Mean

Standard Deviation

nanogram/milliliter (ng/mL)

Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG0030 affected16 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0019 affected111 at risk EG0023 affected56 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00110 affected111 at risk EG0023 affected56 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Palpitations	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Restrictive cardiomyopathy	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Angle closure glaucoma	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Diplopia	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Uveitis	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA V13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected111 at risk EG0021 affected56 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected111 at risk EG0022 affected56 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0015 affected111 at risk EG0020 affected56 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected111 at risk EG0022 affected56 at risk EG003
Asthenia	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected111 at risk EG0020 affected56 at risk EG003
Chest pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected111 at risk EG0020 affected56 at risk EG003
Haemorrhagic cyst	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Mucosal inflammation	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected111 at risk EG0020 affected56 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0021 affected56 at risk EG003
Thrombosis in device	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Anal abscess	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Breast abscess	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Catheter site infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected111 at risk EG0020 affected56 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Enterobacter infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Groin abscess	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0021 affected56 at risk EG003
Influenza	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0021 affected56 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected111 at risk EG0020 affected56 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Weight decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
White blood cell count decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected111 at risk EG0021 affected56 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Metastases to nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Lethargy	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Syncope	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0022 affected56 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected111 at risk EG0021 affected56 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0021 affected56 at risk EG003
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0022 affected56 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0021 affected56 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected111 at risk EG0020 affected56 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Capillary leak syndrome	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected111 at risk EG0020 affected56 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Hypotension	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected111 at risk EG0020 affected56 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Convulsion	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00110 affected111 at risk EG00213 affected56 at risk EG0031 affected16 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected111 at risk EG0020 affected56 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00115 affected111 at risk EG00212 affected56 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00139 affected111 at risk EG00220 affected56 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00115 affected111 at risk EG0024 affected56 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00133 affected111 at risk EG00211 affected56 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00126 affected111 at risk EG0025 affected56 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected111 at risk EG0026 affected56 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00137 affected111 at risk EG00212 affected56 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected6 at risk EG00169 affected111 at risk EG00224 affected56 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected111 at risk EG0024 affected56 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00116 affected111 at risk EG0026 affected56 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected111 at risk EG0020 affected56 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG0018 affected111 at risk EG0024 affected56 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected111 at risk EG0020 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected6 at risk EG00154 affected111 at risk EG00219 affected56 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00111 affected111 at risk EG0025 affected56 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected111 at risk EG0020 affected56 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00147 affected111 at risk EG0026 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00142 affected111 at risk EG00217 affected56 at risk EG003
Asthenia	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00139 affected111 at risk EG00210 affected56 at risk EG003
Chest pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0027 affected56 at risk EG003
Chills	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected111 at risk EG0026 affected56 at risk EG003
Fatigue	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00152 affected111 at risk EG00224 affected56 at risk EG003
Mucosal inflammation	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00142 affected111 at risk EG00212 affected56 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00118 affected111 at risk EG00213 affected56 at risk EG003
Pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0017 affected111 at risk EG0029 affected56 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00122 affected111 at risk EG00210 affected56 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected111 at risk EG0026 affected56 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0017 affected111 at risk EG0024 affected56 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00114 affected111 at risk EG0024 affected56 at risk EG003
Weight decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00116 affected111 at risk EG0020 affected56 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00136 affected111 at risk EG00213 affected56 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00112 affected111 at risk EG0020 affected56 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00121 affected111 at risk EG00210 affected56 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00121 affected111 at risk EG00211 affected56 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00118 affected111 at risk EG00211 affected56 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00110 affected111 at risk EG0023 affected56 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0016 affected111 at risk EG0023 affected56 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0019 affected111 at risk EG0025 affected56 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00122 affected111 at risk EG0027 affected56 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00125 affected111 at risk EG00210 affected56 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00122 affected111 at risk EG0026 affected56 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00125 affected111 at risk EG00210 affected56 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00127 affected111 at risk EG00213 affected56 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0019 affected111 at risk EG0023 affected56 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00114 affected111 at risk EG0028 affected56 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00113 affected111 at risk EG0025 affected56 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00116 affected111 at risk EG0026 affected56 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0019 affected111 at risk EG0025 affected56 at risk EG003
Depression	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected111 at risk EG0024 affected56 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00120 affected111 at risk EG0027 affected56 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected111 at risk EG0023 affected56 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected111 at risk EG0020 affected56 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00118 affected111 at risk EG00214 affected56 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00110 affected111 at risk EG0024 affected56 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00123 affected111 at risk EG00210 affected56 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00130 affected111 at risk EG00210 affected56 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected6 at risk EG00120 affected111 at risk EG0028 affected56 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0017 affected111 at risk EG0025 affected56 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00156 affected111 at risk EG00230 affected56 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0017 affected111 at risk EG0020 affected56 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00114 affected111 at risk EG0027 affected56 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0019 affected111 at risk EG0024 affected56 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected111 at risk EG0020 affected56 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected6 at risk EG00123 affected111 at risk EG00214 affected56 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0018 affected111 at risk EG0020 affected56 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG00111 affected111 at risk EG0020 affected56 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00113 affected111 at risk EG0025 affected56 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG00126 affected111 at risk EG0027 affected56 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG00110 affected111 at risk EG0020 affected56 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected6 at risk EG00136 affected111 at risk EG0023 affected56 at risk EG003
Bradycardia	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Tachycardia	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0023 affected56 at risk EG003
Dacryostenosis acquired	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Glaucoma	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Keratitis	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Ocular hyperaemia	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vision blurred	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Abdominal discomfort	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Dental caries	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Flatulence	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0023 affected56 at risk EG003
Haemorrhoidal haemorrhage	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Odynophagia	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Toothache	Vascular disorders	MedDRA V13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0024 affected56 at risk EG003
Axillary pain	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Irritability	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Cellulitis	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Infected sebaceous cyst	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Oral candidiasis	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Rhinitis	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Tooth abscess	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Tooth infection	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vulvovaginal candidiasis	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vulvovaginal mycotic infection	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Skin laceration	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Alanine aminotransferase	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Aspartate aminotransferase	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Haemoglobin	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Neutrophil count	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Neutrophil count decreased	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
White blood cell count decreased	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0023 affected56 at risk EG003
Hypoalbuminaemia	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Pain in jaw	Immune system disorders	MedDRA V13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Dyskinesia	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Hyperaesthesia	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Migraine	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Haematuria	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Micturition urgency	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Urinary incontinence	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vaginal discharge	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vaginal haemorrhage	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vulvovaginal discomfort	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Vulvovaginal pain	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Nasal congestion	Immune system disorders	MedDRA V13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Nasal discomfort	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Productive cough	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Rhinitis allergic	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Sputum discoloured	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Upper-airway cough syndrome	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Wheezing	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Hirsutism	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Onychalgia	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Pain of skin	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Rash erythematous	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Skin reaction	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Umbilical erythema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Urticaria	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Flushing	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Hypotension	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected111 at risk EG0025 affected56 at risk EG003
Eye pain	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0023 affected56 at risk EG003
Abdominal distension	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0023 affected56 at risk EG003
Catheter site pain	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0024 affected56 at risk EG003
Face oedema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0024 affected56 at risk EG003
Oedema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0025 affected56 at risk EG003
Dyspnoea exertional	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0023 affected56 at risk EG003
Pleural effusion	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0025 affected56 at risk EG003
Hot flush	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0024 affected56 at risk EG003
Lymphoedema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0026 affected56 at risk EG003
Lymphadenopathy	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Eyelid oedema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Hyperchlorhydria	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Oral discomfort	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Retching	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Catheter site erythema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Chest discomfort	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Influenza like illness	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Influenza	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Sinusitis	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Transaminases increased	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Flank pain	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Groin pain	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Muscle fatigue	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Balance disorder	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Facial neuralgia	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Sinus headache	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Proteinuria	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Postnasal drip	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Eczema	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003
Hyperkeratosis	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected6 at risk EG0010 affected111 at risk EG0020 affected56 at risk EG003

ID	Title	Description
BG000	Axitinib + Docetaxel (Phase 1, Lead-in)	Axitinib (AG-013736) 5 mg tablet orally twice daily BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
BG001	Axitinib + Docetaxel (Phase 2, Double-blind)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
BG002	Docetaxel + Placebo (Double-blind)	Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued with axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
BG003	Total	Total of all reporting groups

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D001549	Benzamides
D000577	Amides
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D007191	Indazoles
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
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	Axitinib + Docetaxel (Phase-1 Lead-in)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.	1	6	6	6
EG001	Axitinib + Docetaxel (Phase 2, Double-blind)	Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.	54	111	111	111
EG002	Docetaxel + Placebo (Phase 2, Double-blind)	Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.	17	56	56	56
EG003	Axitinib (Phase 2, Open-label)	Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.	2	16	12	16