A Pivotal Study Of SU011248 In The Treatment Of Patients... | NCT00077974

NCT00077974

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: SU011248

Name	Type	Description	Arm Group Labels	Other Names
SU011248	Drug	50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)	Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Secondary Outcomes

Measure	Description	Time Frame
Time to Tumor Progression (TTP)	Time in weeks 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) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Duarte	California	91010-3000	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28410911	Derived	de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
27238653	Derived

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

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

ID	Title	Description
BG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG00087

>= 65 years

Title	Measurements
	BG00019

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039
Male	BG00067

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

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.

Posted

Number

participants

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000106

Title

Denominators

Categories

Title	Measurements
	OG00035

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						Percent	33				95	24.2	42.8			Using exact method based on binomial distribution. Percent equals n divided by N times 100.	No	Superiority or Other

Secondary

Time to Tumor Progression (TTP)

Time in weeks 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) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

ITT

Posted

Median

95% Confidence Interval

weeks

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Secondary

Duration of Response (DR)

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. 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) divided by 7.

DR was calculated for the subgroup of patients with a confirmed objective tumor response.

ITT subgroup of patients with a confirmed objective tumor response

Posted

Median

95% Confidence Interval

weeks

Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).

ITT

Posted

Median

95% Confidence Interval

weeks

From start of study treatment until death

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Secondary

Progression-free Survival (PFS)

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

ITT

Posted

Median

95% Confidence Interval

weeks

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Secondary

Percent Chance of Patient Survival

Probability of survival 1 year and 2 years after the first dose of study treatment

ITT

Posted

Number

percent chance of survival

From start of study treatment until death

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000106

Secondary

Observed Plasma Trough Concentrations of Sunitinib

Observed plasma trough (predose) (Cmin) concentrations of sunitinib

Pharmacokinetic analysis population

Posted

Mean

Standard Deviation

nanograms per milliliter

Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000104

Secondary

Observed Plasma Trough Concentrations of Sunitinib Metabolite

Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)

Pharmacokinetic analysis population

Posted

Mean

Standard Deviation

nanograms per milliliter

Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000106

Secondary

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite

Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)

Pharmacokinetic analysis population

Posted

Mean

Standard Deviation

nanograms per milliliter

Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000106

Secondary

Dose Corrected Plasma Trough Concentrations of Sunitinib

Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

Pharmacokinetic analysis population

Posted

Mean

Standard Deviation

nanograms per milliliter

Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Secondary

Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite

Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

Pharmacokinetic analysis population

Posted

Mean

Standard Deviation

nanograms per milliliter

Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Secondary

Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite

Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.

Pharmacokinetic analysis population

Posted

Mean

Standard Deviation

nanograms per milliliter

Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater

ID	Title	Description
OG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)			46	106	106	106

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected106 at risk
Thrombocytopenia	Blood and lymphatic system disorders		Systematic Assessment	EG0001 affected106 at risk
Acute myocardial infarction	Cardiac disorders		Systematic Assessment	EG0002 affected106 at risk
Cardiac failure congestive	Cardiac disorders		Systematic Assessment	EG0001 affected106 at risk
Myocardial infarction	Cardiac disorders		Systematic Assessment	EG0002 affected106 at risk
Myocardial ischaemia	Cardiac disorders		Systematic Assessment	EG0001 affected106 at risk
Adrenocortical insufficiency acute	Endocrine disorders		Systematic Assessment	EG0001 affected106 at risk
Abdominal pain	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Diarrhoea	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Intestinal obstruction	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Pancreatitis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Rectal haemorrhage	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Stomatitis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected106 at risk
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG0002 affected106 at risk
Disease progression	General disorders		Systematic Assessment	EG0007 affected106 at risk
Fatigue	General disorders		Systematic Assessment	EG0001 affected106 at risk
Impaired healing	General disorders		Systematic Assessment	EG0001 affected106 at risk
Non-cardiac chest pain	General disorders		Systematic Assessment	EG0002 affected106 at risk
Oedema peripheral	General disorders		Systematic Assessment	EG0001 affected106 at risk
Portal vein thrombosis	Hepatobiliary disorders		Systematic Assessment	EG0001 affected106 at risk
Abscess	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Anorectal infection	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Clostridium difficile colitis	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Gastroenteritis viral	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Infection	Infections and infestations		Systematic Assessment	EG0002 affected106 at risk
Pancreatic abscess	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Perirectal abscess	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Pneumonia	Infections and infestations		Systematic Assessment	EG0003 affected106 at risk
Sepsis	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Staphylococcal infection	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Urinary tract infection	Infections and infestations		Systematic Assessment	EG0001 affected106 at risk
Femur fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected106 at risk
Skeletal injury	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected106 at risk
Ejection fraction decreased	Investigations		Systematic Assessment	EG0001 affected106 at risk
International normalised ratio increased	Investigations		Systematic Assessment	EG0001 affected106 at risk
Oxygen saturation decreased	Investigations		Systematic Assessment	EG0001 affected106 at risk
Platelet count decreased	Investigations		Systematic Assessment	EG0001 affected106 at risk
Dehydration	Metabolism and nutrition disorders		Systematic Assessment	EG0005 affected106 at risk
Failure to thrive	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected106 at risk
Hypercalcaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected106 at risk
Hyperglycaemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected106 at risk
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0002 affected106 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected106 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0002 affected106 at risk
Convulsion	Nervous system disorders		Systematic Assessment	EG0001 affected106 at risk
Hypoglycaemic encephalopathy	Nervous system disorders		Systematic Assessment	EG0001 affected106 at risk
Reversible posterior leukoencephalopathy syndrome	Nervous system disorders		Systematic Assessment	EG0001 affected106 at risk
Speech disorder	Nervous system disorders		Systematic Assessment	EG0001 affected106 at risk
Spinal cord compression	Nervous system disorders		Systematic Assessment	EG0002 affected106 at risk
Syncope	Nervous system disorders		Systematic Assessment	EG0001 affected106 at risk
Depression	Psychiatric disorders		Systematic Assessment	EG0001 affected106 at risk
Mental status changes	Psychiatric disorders		Systematic Assessment	EG0002 affected106 at risk
Renal failure	Renal and urinary disorders		Systematic Assessment	EG0003 affected106 at risk
Renal failure acute	Renal and urinary disorders		Systematic Assessment	EG0002 affected106 at risk
Ureteric obstruction	Renal and urinary disorders		Systematic Assessment	EG0001 affected106 at risk
Uterine haemorrhage	Reproductive system and breast disorders		Systematic Assessment	EG0001 affected106 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected106 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected106 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected106 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected106 at risk
Petechiae	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0001 affected106 at risk
Purpura	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0001 affected106 at risk
Fracture treatment	Surgical and medical procedures		Systematic Assessment	EG0001 affected106 at risk
Tumour excision	Surgical and medical procedures		Systematic Assessment	EG0001 affected106 at risk
Aortic stenosis	Vascular disorders		Systematic Assessment	EG0001 affected106 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00019 affected106 at risk
Neutropenia	Blood and lymphatic system disorders		Systematic Assessment	EG00011 affected106 at risk
Thrombocytopenia	Blood and lymphatic system disorders		Systematic Assessment	EG00011 affected106 at risk
Hypothyroidism	Endocrine disorders		Systematic Assessment	EG00021 affected106 at risk
Lacrimation increased	Eye disorders		Systematic Assessment	EG0007 affected106 at risk
Abdominal discomfort	Gastrointestinal disorders		Systematic Assessment	EG0007 affected106 at risk
Abdominal pain	Gastrointestinal disorders		Systematic Assessment	EG00019 affected106 at risk
Abdominal pain upper	Gastrointestinal disorders		Systematic Assessment	EG00010 affected106 at risk
Constipation	Gastrointestinal disorders		Systematic Assessment	EG00040 affected106 at risk
Diarrhoea	Gastrointestinal disorders		Systematic Assessment	EG00067 affected106 at risk
Dry mouth	Gastrointestinal disorders		Systematic Assessment	EG00010 affected106 at risk
Dyspepsia	Gastrointestinal disorders		Systematic Assessment	EG00049 affected106 at risk
Dysphagia	Gastrointestinal disorders		Systematic Assessment	EG0007 affected106 at risk
Flatulence	Gastrointestinal disorders		Systematic Assessment	EG00011 affected106 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders		Systematic Assessment	EG00012 affected106 at risk
Glossodynia	Gastrointestinal disorders		Systematic Assessment	EG00011 affected106 at risk
Haematochezia	Gastrointestinal disorders		Systematic Assessment	EG0006 affected106 at risk
Haemorrhoids	Gastrointestinal disorders		Systematic Assessment	EG0009 affected106 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG00066 affected106 at risk
Oral pain	Gastrointestinal disorders		Systematic Assessment	EG00012 affected106 at risk
Stomatitis	Gastrointestinal disorders		Systematic Assessment	EG00043 affected106 at risk
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG00051 affected106 at risk
Chest discomfort	General disorders		Systematic Assessment	EG0007 affected106 at risk
Chest pain	General disorders		Systematic Assessment	EG00018 affected106 at risk
Chills	General disorders		Systematic Assessment	EG00020 affected106 at risk
Fatigue	General disorders		Systematic Assessment	EG00084 affected106 at risk
Mucosal inflammation	General disorders		Systematic Assessment	EG00028 affected106 at risk
Oedema	General disorders		Systematic Assessment	EG00010 affected106 at risk
Oedema peripheral	General disorders		Systematic Assessment	EG00022 affected106 at risk
Pain	General disorders		Systematic Assessment	EG00013 affected106 at risk
Pyrexia	General disorders		Systematic Assessment	EG00019 affected106 at risk
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG00010 affected106 at risk
Sinusitis	Infections and infestations		Systematic Assessment	EG0009 affected106 at risk
Upper respiratory tract infection	Infections and infestations		Systematic Assessment	EG00022 affected106 at risk
Urinary tract infection	Infections and infestations		Systematic Assessment	EG0009 affected106 at risk
Aspartate aminotransferase increased	Investigations		Systematic Assessment	EG0006 affected106 at risk
Blood creatinine increased	Investigations		Systematic Assessment	EG0009 affected106 at risk
Ejection fraction decreased	Investigations		Systematic Assessment	EG00019 affected106 at risk
Haemoglobin decreased	Investigations		Systematic Assessment	EG0008 affected106 at risk
Lipase increased	Investigations		Systematic Assessment	EG00012 affected106 at risk
Neutrophil count decreased	Investigations		Systematic Assessment	EG00011 affected106 at risk
Platelet count decreased	Investigations		Systematic Assessment	EG00016 affected106 at risk
Weight decreased	Investigations		Systematic Assessment	EG00018 affected106 at risk
Weight increased	Investigations		Systematic Assessment	EG0007 affected106 at risk
White blood cell count decreased	Investigations		Systematic Assessment	EG00012 affected106 at risk
Anorexia	Metabolism and nutrition disorders		Systematic Assessment	EG00043 affected106 at risk
Dehydration	Metabolism and nutrition disorders		Systematic Assessment	EG00011 affected106 at risk
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00024 affected106 at risk
Back pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00027 affected106 at risk
Bone pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00013 affected106 at risk
Flank pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0009 affected106 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00010 affected106 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0008 affected106 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00012 affected106 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00014 affected106 at risk
Myalgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00021 affected106 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG00037 affected106 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG00019 affected106 at risk
Dysgeusia	Nervous system disorders		Systematic Assessment	EG00054 affected106 at risk
Headache	Nervous system disorders		Systematic Assessment	EG00032 affected106 at risk
Hypoaesthesia	Nervous system disorders		Systematic Assessment	EG0007 affected106 at risk
Paraesthesia	Nervous system disorders		Systematic Assessment	EG00010 affected106 at risk
Peripheral sensory neuropathy	Nervous system disorders		Systematic Assessment	EG0006 affected106 at risk
Anxiety	Psychiatric disorders		Systematic Assessment	EG00010 affected106 at risk
Depression	Psychiatric disorders		Systematic Assessment	EG00012 affected106 at risk
Insomnia	Psychiatric disorders		Systematic Assessment	EG00014 affected106 at risk
Dysuria	Renal and urinary disorders		Systematic Assessment	EG00010 affected106 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00026 affected106 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0007 affected106 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00027 affected106 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00012 affected106 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00025 affected106 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0009 affected106 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0007 affected106 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00011 affected106 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0008 affected106 at risk
Alopecia	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00014 affected106 at risk
Blister	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00010 affected106 at risk
Dry skin	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00023 affected106 at risk
Erythema	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00015 affected106 at risk
Hair colour changes	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00021 affected106 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0006 affected106 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00030 affected106 at risk
Periorbital oedema	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00012 affected106 at risk
Pruritus	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0008 affected106 at risk
Rash	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00038 affected106 at risk
Skin discolouration	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00035 affected106 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00012 affected106 at risk
Skin lesion	Skin and subcutaneous tissue disorders		Systematic Assessment	EG00010 affected106 at risk
Skin reaction	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0008 affected106 at risk
Hot flush	Vascular disorders		Systematic Assessment	EG0007 affected106 at risk
Hypertension	Vascular disorders		Systematic Assessment	EG00038 affected106 at risk

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D000077210	Sunitinib

Ancestor Terms

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

Title

Denominators

Categories

Cycle 1 Day 28 (n = 103)

Title	Measurements
	OG00046.82± 24.19

Cycle 2 Day 28 (n = 81)

Title	Measurements
	OG00050.13± 24.66

Cycle 3 Day 28 (n = 73)

Title	Measurements
	OG00049.36± 25.26

Cycle 4 Day 28 (n = 66)

Title	Measurements
	OG00053.18± 22.62

Cycle 5 Day 1 (n = 63)

Title	Measurements
	OG0001.55± 1.48

Cycle 6 Day 1 (n = 59)

Title	Measurements
	OG0001.44± 1.37

Cycle 7 Day 1 (n = 52)

Title	Measurements
	OG0001.51± 1.90

Cycle 8 Day 1 (n = 48)

Title	Measurements
	OG0001.60± 1.38

Cycle 9 Day 1 (n = 46)

Title	Measurements
	OG0001.60± 1.58

Cycle 10 Day 1 (n = 41)

Title	Measurements
	OG0001.69± 1.97

Cycle 11 Day 1 (n = 38)

Title	Measurements
	OG0002.05± 3.00

Cycle 12 Day 1 (n = 34)

Title	Measurements
	OG0001.72± 1.66

Cycle 13 Day 1 (n = 30)

Title	Measurements
	OG0001.74± 1.57

Cycle 14 Day 1 (n = 30)

Title	Measurements
	OG0001.60± 1.45

Cycle 15 Day 1 (n = 24)

Title	Measurements
	OG0001.56± 2.17

Cycle 16 Day 1 (n = 24)

Title	Measurements
	OG0001.46± 1.23

Cycle 17 Day 1 (n = 19)

Title	Measurements
	OG0001.42± 1.65

Cycle 18 Day 1 (n = 16)

Title	Measurements
	OG0002.20± 2.17

Cycle 19 Day 1 (n = 14)

Title	Measurements
	OG0001.34± 1.18

Cycle 20 Day 1 (n = 12)

Title	Measurements
	OG0002.96± 3.53

Cycle 21 Day 1 (n = 11)

Title	Measurements
	OG0002.53± 2.07

Cycle 22 Day 1 (n = 11)

Title	Measurements
	OG0002.18± 2.57

Cycle 23 Day 1 (n = 7)

Title	Measurements
	OG0003.14± 2.70

Cycle 24 Day 1 (n = 7)

Title	Measurements
	OG0002.75± 1.86

Cycle 25 Day 1 (n = 6)

Title	Measurements
	OG0001.99± 1.37

Cycle 26 Day 1 (n = 6)

Title	Measurements
	OG0002.46± 2.43

Cycle 27 Day 1 (n = 6)

Title	Measurements
	OG0001.20± 1.21

Cycle 28 Day 1 (n = 4)

Title	Measurements
	OG0001.75± 1.61

Cycle 29 Day 1 (n = 5)

Title	Measurements
	OG0002.93± 3.64

Cycle 30 Day 1 (n = 4)

Title	Measurements
	OG0001.02± 0.90

Title

Denominators

Categories

Cycle 1 Day 28 (n = 103)

Title	Measurements
	OG00026.44± 15.66

Cycle 2 Day 28 (n = 81)

Title	Measurements
	OG00028.21± 17.21

Cycle 3 Day 28 (n = 73)

Title	Measurements
	OG00028.32± 18.38

Cycle 4 Day 28 (n = 66)

Title	Measurements
	OG00028.54± 16.93

Cycle 5 Day 1 (n = 63)

Title	Measurements
	OG0002.50± 1.60

Cycle 6 Day 1 (n = 59)

Title	Measurements
	OG0002.64± 1.67

Cycle 7 Day 1 (n = 52)

Title	Measurements
	OG0002.64± 1.98

Cycle 8 Day 1 (n = 48)

Title	Measurements
	OG0002.66± 1.68

Cycle 9 Day 1 (n = 46)

Title	Measurements
	OG0002.81± 2.32

Cycle 10 Day 1 (n = 41)

Title	Measurements
	OG0002.54± 1.87

Cycle 11 Day 1 (n = 38)

Title	Measurements
	OG0002.78± 3.40

Cycle 12 Day 1 (n = 34)

Title	Measurements
	OG0002.67± 2.29

Cycle 13 Day 1 (n = 30)

Title	Measurements
	OG0002.77± 2.03

Cycle 14 Day 1 (n = 30)

Title	Measurements
	OG0002.49± 2.05

Cycle 15 Day 1 (n = 24)

Title	Measurements
	OG0002.51± 2.98

Cycle 16 Day 1 (n = 24)

Title	Measurements
	OG0002.30± 1.84

Cycle 17 Day 1 (n = 19)

Title	Measurements
	OG0001.83± 1.49

Cycle 18 Day 1 (n = 16)

Title	Measurements
	OG0002.16± 1.07

Cycle 19 Day 1 (n = 14)

Title	Measurements
	OG0002.06± 1.82

Cycle 20 Day 1 (n = 12)

Title	Measurements
	OG0002.92± 1.86

Cycle 21 Day 1 (n = 11)

Title	Measurements
	OG0003.13± 2.19

Cycle 22 Day 1 (n = 11)

Title	Measurements
	OG0003.24± 3.12

Cycle 23 Day 1 (n = 7)

Title	Measurements
	OG0003.10± 2.25

Cycle 24 Day 1 (n = 7)

Title	Measurements
	OG0002.64± 1.68

Cycle 25 Day 1 (n = 6)

Title	Measurements
	OG0001.99± 1.07

Cycle 26 Day 1 (n = 6)

Title	Measurements
	OG0002.60± 2.26

Cycle 27 Day 1 (n = 6)

Title	Measurements
	OG0001.36± 1.22

Cycle 28 Day 1 (n = 4)

Title	Measurements
	OG0001.81± 1.20

Cycle 29 Day 1 (n = 5)

Title	Measurements
	OG0002.43± 2.12

Cycle 30 Day 1 (n = 4)

Title	Measurements
	OG0001.10± 0.73

Title

Denominators

Categories

Cycle 1 Day 28 (n = 103)

Title	Measurements
	OG00073.26± 36.85

Cycle 2 Day 28 (n = 81)

Title	Measurements
	OG00078.34± 39.03

Cycle 3 Day 28 (n = 73)

Title	Measurements
	OG00077.68± 39.84

Cycle 4 Day 28 (n = 66)

Title	Measurements
	OG00081.71± 36.55

Cycle 5 Day 1 (n = 63)

Title	Measurements
	OG0004.04± 2.80

Cycle 6 Day 1 (n = 59)

Title	Measurements
	OG0004.08± 2.72

Cycle 7 Day 1 (n = 52)

Title	Measurements
	OG0004.15± 3.57

Cycle 8 Day 1 (n = 48)

Title	Measurements
	OG0004.26± 2.78

Cycle 9 Day 1 (n = 46)

Title	Measurements
	OG0004.41± 3.65

Cycle 10 Day 1 (n = 41)

Title	Measurements
	OG0004.23± 3.69

Cycle 11 Day 1 (n = 38)

Title	Measurements
	OG0004.83± 6.34

Cycle 12 Day 1 (n = 34)

Title	Measurements
	OG0004.39± 3.69

Cycle 13 Day 1 (n = 30)

Title	Measurements
	OG0004.52± 3.36

Cycle 14 Day 1 (n = 30)

Title	Measurements
	OG0004.09± 3.37

Cycle 15 Day 1 (n = 24)

Title	Measurements
	OG0004.07± 5.00

Cycle 16 Day 1 (n = 24)

Title	Measurements
	OG0003.75± 2.63

Cycle 17 Day 1 (n = 19)

Title	Measurements
	OG0003.25± 3.03

Cycle 18 Day 1 (n = 16)

Title	Measurements
	OG0004.35± 2.90

Cycle 19 Day 1 (n = 14)

Title	Measurements
	OG0003.40± 2.87

Cycle 20 Day 1 (n = 12)

Title	Measurements
	OG0005.88± 5.19

Cycle 21 Day 1 (n = 11)

Title	Measurements
	OG0005.66± 4.09

Cycle 22 Day 1 (n = 11)

Title	Measurements
	OG0005.43± 5.61

Cycle 23 Day 1 (n = 7)

Title	Measurements
	OG0006.24± 4.78

Cycle 24 Day 1 (n = 7)

Title	Measurements
	OG0005.39± 3.31

Cycle 25 Day 1 (n = 6)

Title	Measurements
	OG0003.97± 2.32

Cycle 26 Day 1 (n = 6)

Title	Measurements
	OG0005.06± 4.61

Cycle 27 Day 1 (n = 6)

Title	Measurements
	OG0002.55± 2.41

Cycle 28 Day 1 (n = 4)

Title	Measurements
	OG0003.56± 2.77

Cycle 29 Day 1 (n = 5)

Title	Measurements
	OG0005.36± 5.74

Cycle 30 Day 1 (n = 4)

Title	Measurements
	OG0002.13± 1.57