Trial Outcomes & Findings for Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases (NCT NCT00372775)

Last Updated: 2011-02-24

Results Overview

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)

Results posted on

2011-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib Sunitinib 37.5 mg oral capsule daily
Overall Study STARTED	66
Overall Study Received Treatment	64
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	63

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Sunitinib 37.5 mg oral capsule daily
Overall Study Adverse Event	8
Overall Study Death	15
Overall Study Objective progression or relapse	30
Overall Study Global deterioration of health status	6
Overall Study Withdrawal by Subject	1
Overall Study Other	1
Overall Study Not Treated	2

Baseline Characteristics

Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Age, Customized Between 18 and 44 years	4 Participants n=5 Participants
Age, Customized Between 45 and 64 years	40 Participants n=5 Participants
Age, Customized >= 65 years	20 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)

Population: Intent-to-treat (ITT): all participants enrolled in the study who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Progression-Free Survival (PFS)	9.4 Weeks Interval 7.5 to 13.1

SECONDARY outcome

Timeframe: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)

Population: ITT

Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Time to Tumor Progression (TTP)	15.1 Weeks Interval 8.4 to 15.8

SECONDARY outcome

Timeframe: Baseline, Day 28 to focal neurological deficit (up to 1 year)

Population: ITT

Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Time to Neurological Progression (TNP)	8.1 Weeks Interval 0.4 to 58.8

SECONDARY outcome

Timeframe: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49

Population: ITT with measurable disease at baseline.

Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Outcome measures
Measure	Sunitinib n=61 Participants Sunitinib 37.5 mg oral capsule daily
Number of Participants With Objective Disease Response	1 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)

Population: ITT

Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Time to Objective Intracranial Progression	15.4 Weeks Interval 12.1 to 24.8

SECONDARY outcome

Timeframe: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49

Population: ITT with measurable intracranial disease at baseline.

Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.

Outcome measures

Outcome measures
Measure	Sunitinib n=23 Participants Sunitinib 37.5 mg oral capsule daily
Number of Participants With Intracranial Objective Disease Response	1 Participants

SECONDARY outcome

Timeframe: Day 7 of Week 4 and every 4 weeks up to 1 year

Population: ITT. DR only calculated for the subgroup of participants with an objective tumor response.

DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.

Outcome measures

Outcome measures
Measure	Sunitinib n=1 Participants Sunitinib 37.5 mg oral capsule daily
Duration of Response (DR) Overall	32.1 Weeks
Duration of Response (DR) Intracranial	8.26 Weeks

SECONDARY outcome

Timeframe: Baseline until death (up to 1 year)

Population: ITT. In the absence of confirmation of death, survival time was censored to last date of known contact.

OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Overall Survival (OS)	5.8 Months Interval 3.1 to 8.2

SECONDARY outcome

Timeframe: Year 1

Population: ITT

Percentage of those surviving at end of 1 year from the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Percentage of Participants Surviving at 1 Year	23.4 Percentage of participants Interval 14.0 to 34.3

SECONDARY outcome

Timeframe: Baseline until death (up to 1 year)

Population: ITT

Number of deaths determined to be intracranial versus systemic progression, according to investigators'assessment.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Number of Deaths Due to Intracranial Versus Systemic Progression Systemic Progression	48 Participants
Number of Deaths Due to Intracranial Versus Systemic Progression Intracranial Progression	0 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)

Population: ITT population of participants with post baseline patient-reported outcome data

Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.

Outcome measures

Outcome measures
Measure	Sunitinib n=45 Participants Sunitinib 37.5 mg oral capsule daily
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Baseline	17.62 Scores on a scale Interval 16.01 to 19.22
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 2, Day 1	0.52 Scores on a scale Interval -0.89 to 1.92
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 3, Day 1	1.11 Scores on a scale Interval -0.57 to 2.8
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 4, Day 1	-0.48 Scores on a scale Interval -2.94 to 1.99
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 5, Day 1	0.64 Scores on a scale Interval -1.03 to 2.31
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 6, Day 1	-0.63 Scores on a scale Interval -2.3 to 1.05
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 7, Day 1	-0.66 Scores on a scale Interval -2.14 to 0.82
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 8, Day 1	-0.66 Scores on a scale Interval -1.76 to 0.45
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 9, Day 1	-0.60 Scores on a scale Interval -2.55 to 1.35
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle10, Day 1	-0.12 Scores on a scale Interval -2.47 to 2.23
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 11, Day 1	-0.20 Scores on a scale Interval -2.96 to 2.56
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 12, Day 1	-0.40 Scores on a scale Interval -2.99 to 2.19
Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score Cycle 13, Day 1	-0.80 Scores on a scale Interval -10.96 to 9.36

SECONDARY outcome

Timeframe: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)

Population: ITT population of participants with post baseline patient-reported outcome data

Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.

Outcome measures

Outcome measures
Measure	Sunitinib n=45 Participants Sunitinib 37.5 mg oral capsule daily
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Baseline	45.72 Scores on a scale Interval 43.52 to 47.92
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 2, Day 1	-1.25 Scores on a scale Interval -2.84 to 0.34
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 3, Day 1	-0.58 Scores on a scale Interval -3.52 to 2.37
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 4, Day 1	0.66 Scores on a scale Interval -2.34 to 3.65
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 5, Day 1	-1.87 Scores on a scale Interval -5.21 to 1.46
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 6, Day 1	-1.92 Scores on a scale Interval -5.96 to 2.12
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 7, Day 1	-2.00 Scores on a scale Interval -5.8 to 1.8
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 8, Day 1	-0.73 Scores on a scale Interval -4.46 to 2.99
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 9, Day 1	0.40 Scores on a scale Interval -3.07 to 3.88
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 10, Day 1	-1.83 Scores on a scale Interval -5.11 to 1.45
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 11, Day 1	-1.50 Scores on a scale Interval -6.09 to 3.09
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 12, Day 1	-4.50 Scores on a scale Interval -15.33 to 6.33
Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score Cycle 13, Day 1	1.21 Scores on a scale Interval -8.77 to 11.2

SECONDARY outcome

Timeframe: Day 1 of Week 5, 9, and 13

Population: ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.

A single blood sample (4 milliliters \[mL\]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Trough Plasma Concentrations (Ctrough) of Sunitinib Cycle 2, Day 1 (n = 26)	50.89 nanograms per milliliter (ng/mL) Standard Deviation 20.47
Trough Plasma Concentrations (Ctrough) of Sunitinib Cycle 3, Day 1 (n = 21)	46.27 nanograms per milliliter (ng/mL) Standard Deviation 17.97
Trough Plasma Concentrations (Ctrough) of Sunitinib Cycle 4, Day 1 (n = 20)	51.10 nanograms per milliliter (ng/mL) Standard Deviation 23.13

SECONDARY outcome

Timeframe: Day 1 of Week 5, 9, and 13

A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.

Outcome measures

Outcome measures
Measure	Sunitinib n=64 Participants Sunitinib 37.5 mg oral capsule daily
Ctrough of Sunitinib Metabolite (SU012662) Cycle 2, Day 1 (n = 26)	33.85 ng/mL Standard Deviation 17.64
Ctrough of Sunitinib Metabolite (SU012662) Cycle 3, Day 1 (n = 21)	28.45 ng/mL Standard Deviation 15.73
Ctrough of Sunitinib Metabolite (SU012662) Cycle 4, Day 1 ( n = 20)	28.91 ng/mL Standard Deviation 18.82

SECONDARY outcome

Timeframe: Day 1 prior to dosing

Population: ITT. c-Kit, Flt-3 and c-Fms with blood count samples collected; however, no statistical analyses performed since power was insufficient.

A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Week 1 and every 4 weeks up to 1 year

Population: ITT. Only 4 RNA samples were collected and no statistical analyses performed.

Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 of Week 1 and every 4 weeks up to 1 year

Population: ITT. Only 4 RNA samples were collected and no statistical analyses performed.

PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase \[GAPDH\] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.

Outcome measures

Outcome data not reported

Adverse Events

Sunitinib

Serious events: 34 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=64 participants at risk Sunitinib 37.5 mg oral capsule daily
Blood and lymphatic system disorders Febrile neutropenia	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac tamponade	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Pericarditis	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Aphthous stomatitis	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Duodenal ulcer	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Glossodynia	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oral pain	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	20.3% 13/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders General physical health deterioration	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Jaundice	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lung infection	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pyelonephritis	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fracture	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Investigations Pulmonary function test decreased	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebellar syndrome	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebral ischaemia	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Epilepsy	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Intentional self-injury	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 1/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.1% 2/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.7% 3/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Sunitinib n=64 participants at risk Sunitinib 37.5 mg oral capsule daily
General disorders Mucosal inflammation	17.2% 11/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	6.2% 4/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	25.0% 16/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	9.4% 6/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 8/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	6.2% 4/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	23.4% 15/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.3% 13/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	18.8% 12/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 8/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	9.4% 6/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	10.9% 7/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	23.4% 15/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	18.8% 12/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	9.4% 6/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	21.9% 14/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	6.2% 4/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	17.2% 11/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	17.2% 11/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	7.8% 5/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	35.9% 23/64 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER