A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer · Source last updated 2018-09-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Number of participants
Interval / dispersion
Not reported
Time frame
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
What was measured
Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later.
The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row.
Analysis population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Groups in this outcome
Sunitinib
Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Placebo
Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Sunitinib
309
Placebo
306
Reported measurements
Palmar-plantar erythrodysaesthesia syndrome
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
13
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
6
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Asthenia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
4
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
3
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Pulmonary embolism
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
3
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Gastrooesophageal reflux disease
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
3
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Ejection fraction decreased
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Left ventricular dysfunction
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Acute myocardial infarction
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Blood creatinine increased
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Dyspepsia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Proteinuria
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Upper gastrointestinal haemorrhage
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Electrocardiogram QT prolonged
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Lethargy
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Transient ischaemic attack
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Depression
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
2
Not reported
Not reported
Not reported
Not reported
Abdominal pain
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Abdominal pain upper
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Acute kidney injury
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Ageusia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Anal inflammation
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Anal pruritus
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Atrial fibrillation
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Atrial flutter
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Diarrhoea
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Disease progression
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Dysgeusia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Electrocardiogram ST segment abnormal
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Embolism venous
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Eyelid oedema
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Gastritis haemorrhagic
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Glossodynia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Hepatic function abnormal
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Hepatitis acute
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Hypercreatininaemia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Hypertransaminasaemia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Hypothyroidism
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Influenza like illness
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Mental status changes
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Mucosal inflammation
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Myalgia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Myocardial infarction
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Myocarditis
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Necrosis
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Nephrotic syndrome
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Oedema peripheral
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pancytopenia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Post procedural infection
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Presyncope
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pyrexia
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Stomatitis
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Therapeutic response unexpected
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Tremor
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Vena cava thrombosis
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Vertigo
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Placebo
0
Not reported
Not reported
Not reported
Not reported
Agitated depression
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Angina unstable
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Brain cancer metastatic
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Hepatitis
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Hypersensitivity
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Metastases to lung
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Mood altered
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Renal impairment
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Tinnitus
Values in Number of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Placebo
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
0
title
Palmar-plantar erythrodysaesthesia syndrome
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
0
title
Hypertension
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
title
Asthenia
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
Fatigue
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
Pulmonary embolism
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
Gastrooesophageal reflux disease
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Ejection fraction decreased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Left ventricular dysfunction
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Acute myocardial infarction
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Blood creatinine increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Dehydration
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Dyspepsia
denoms
counts
group Id
OG000
value
309
group Id
OG001
value
306
units
Participants
description
Participants were followed for AEs from the first day of study treatment until at least 28 days after the last on-study treatment administration, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later.
The treatment was administered to the participants from cycle1/day 1 up to 9 cycles or until relapse, secondary malignancy, death or withdraw for other reasons such as toxicity or withdraw of consent. This table provides the summary of discontinuations de to adverse events. Participants were counted only once in each row.
groups
description
Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
id
OG000
title
Sunitinib
description
Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
id
OG001
title
Placebo
param Type
NUMBER
population Description
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
reporting Status
POSTED
time Frame
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post treatment, or until all serious or study medication-related toxicities had resolved or were determined to be "chronic" or "stable," whichever was later
Triangle