Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer · Source last updated 2017-04-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline to end of study (maximum of 22 weeks)
What was measured
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.
Analysis population: Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.
Groups in this outcome
Sunitinib
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
Pazopanib
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
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
38
Pazopanib
25
Reported measurements
Fatigue
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
5
Not reported
Not reported
Not reported
Not reported
Pazopanib
3
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
4
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
3
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
3
Not reported
Not reported
Not reported
Not reported
Diarrhoea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
2
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
3
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Acute myocardial infarction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Asthenia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Back pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Dyspnoea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Epistaxis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Nasal congestion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Pleural effusion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Transient ischaemic attack
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
2
Not reported
Not reported
Not reported
Not reported
Atrial flutter
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Blood potassium decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Cardiac disorder
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Cardiac failure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Cough
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Decreased appetite
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Dysgeusia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Haematemesis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Haematoma
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Haematuria
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Haemorrhage intracranial
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Headache
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hepatic function abnormal
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Hepatotoxicity
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Infectious peritonitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Influenza
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Influenza like illness
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Mucosal inflammation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Myocardial ischaemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Nausea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Neutropenic infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Ovarian cyst
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Pain in extremity
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Palmar-plantar erythrodysaesthesia syndrome
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Pancytopenia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Proteinuria
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Pyrexia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Rash
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Renal failure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Respiratory failure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Sinusitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Skin ulcer
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Spinal cord compression
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Stomatitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Tooth infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Transaminases increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Urine protein/creatinine ratio decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Weight decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sunitinib
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
3
title
Fatigue
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
title
Vomiting
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
title
Diarrhoea
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Acute myocardial infarction
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Asthenia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Back pain
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Dyspnoea
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Epistaxis
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Hypertension
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
25
units
Participants
description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.
groups
description
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
id
OG000
title
Sunitinib
description
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
id
OG001
title
Pazopanib
param Type
NUMBER
population Description
Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.
reporting Status
POSTED
time Frame
Baseline to end of study (maximum of 22 weeks)
title
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Triangle