Trial Outcomes & Findings for Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor (NCT NCT00137449)
NCT ID: NCT00137449
Last Updated: 2009-09-15
Results Overview
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Planned duration on this protocol of up to 1 year
Results posted on
2009-09-15
Participant Flow
Must have failed prior treatment with imatinib mesylate (IM) \[defined as progression of disease using Response Evaluation Criteria in Solid Tumors(RECIST) or World Health Organization(WHO) criteria, or significant toxicity during treatment with IM precluding further treatment \& Eastern Cooperative Oncology Group(ECOG) performance status of 0-1\]
Participant milestones
| Measure |
AM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
Reasons for withdrawal
| Measure |
AM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|
|
Overall Study
Disease Progression
|
8
|
13
|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
Baseline characteristics by cohort
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25.0 Participants
n=5 Participants
|
|
Age Continuous
|
59.3 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28.0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for \>=24 weeks)
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Number of Participants With Clinical Benefit Response (CBR) According to RECIST
|
15 participants
Interval 31.3 to 68.7
|
17 participants
|
32 participants
|
SECONDARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
Best confirmed response (BCR) defined as best response \[confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)\] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Number of Participants by Best Confirmed Response Category According to RECIST
Complete Response (CR)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants by Best Confirmed Response Category According to RECIST
Partial Response (PR)
|
3 participants
|
5 participants
|
8 participants
|
|
Number of Participants by Best Confirmed Response Category According to RECIST
Stable Disease (SD)
|
20 participants
|
20 participants
|
40 participants
|
|
Number of Participants by Best Confirmed Response Category According to RECIST
Progressive disease (PD)
|
2 participants
|
4 participants
|
6 participants
|
|
Number of Participants by Best Confirmed Response Category According to RECIST
Not evaluable (NE)
|
5 participants
|
1 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Number of Participants With Overall Confirmed Objective Disease Response (ORR)
|
3 participants
|
5 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Duration of Stable Disease
>= 12 weeks
|
19 Participants
|
14 Participants
|
33 Participants
|
|
Duration of Stable Disease
>= 24 weeks
|
12 Participants
|
12 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
Patient was censored
|
12 participants
|
10 participants
|
22 participants
|
|
Progression-free Survival (PFS)
Patient observed to have an event
|
18 participants
|
20 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.
TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Time to Tumor Progression (TTP)
Patient was censored
|
18 participants
|
13 participants
|
31 participants
|
|
Time to Tumor Progression (TTP)
Patient observed to have an event
|
12 participants
|
17 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Planned duration on this protocol of up to 1 yearPopulation: ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8)
DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Duration of Tumor Response (DR) [Descriptive Statistics]
|
32.7 weeks
Interval 32.3 to 35.1
|
40.3 weeks
Interval 17.1 to 51.4
|
33.9 weeks
Interval 17.1 to 51.4
|
SECONDARY outcome
Timeframe: Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.Population: ITT population (all subjects enrolled that received at least 1 dose of study medication).
Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Overall Survival (OS) and One-year Survival [Descriptive Statistics]
Number of subjects alive
|
16 participants
|
17 participants
|
33 participants
|
|
Overall Survival (OS) and One-year Survival [Descriptive Statistics]
Number of subjects dead
|
14 participants
|
13 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 & 15 of each treatment cyclePopulation: ITT population
FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for \>=10 subjects.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Score of FACIT-Fatigue Scale
Baseline Score
|
35.9 score on scale
Standard Deviation 11.13
|
36.3 score on scale
Standard Deviation 13.69
|
36.1 score on scale
Standard Deviation 12.35
|
|
Score of FACIT-Fatigue Scale
Maximum Post-Baseline Score
|
40.6 score on scale
Standard Deviation 10.38
|
42.8 score on scale
Standard Deviation 8.61
|
41.7 score on scale
Standard Deviation 9.50
|
|
Score of FACIT-Fatigue Scale
Minimum Post-Baseline Score
|
26.9 score on scale
Standard Deviation 12.39
|
26.0 score on scale
Standard Deviation 13.87
|
26.4 score on scale
Standard Deviation 13.06
|
SECONDARY outcome
Timeframe: Baseline, Day 1 &15 of each treatment cycle up to 1 year on studyPopulation: ITT population.
EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for \>=10 subjects.
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)
Maximum Increase
|
7.5 score on scale
Interval -68.6 to 45.0
|
10.0 score on scale
Interval -40.0 to 62.0
|
18.0 score on scale
Interval -30.0 to 55.0
|
|
Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)
Maximum Decrease
|
0.0 score on scale
Interval -80.8 to 50.0
|
-10.0 score on scale
Interval -30.0 to 67.0
|
-7.5 score on scale
Interval -80.8 to 62.0
|
SECONDARY outcome
Timeframe: Baseline, Day 1 & 15 of each treatment cycle up to 1 year on studyPopulation: ITT population
EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for \>=10 subjects).
Outcome measures
| Measure |
AM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
n=30 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
Total (Equals AM Plus PM Dose) Sunitinib Malate
n=60 Participants
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|---|
|
Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index
Maximum Increase
|
0.1 score on scale
Interval -0.2 to 0.7
|
0.0 score on scale
Interval -0.6 to 0.8
|
0.1 score on scale
Interval -0.4 to 0.8
|
|
Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index
Maximum Decrease
|
-0.1 score on scale
Interval -0.3 to 0.3
|
-0.8 score on scale
Interval -0.8 to 0.5
|
-0.1 score on scale
Interval -0.8 to 0.3
|
Adverse Events
AM Dose Sunitinib Malate
Serious events: 13 serious events
Other events: 30 other events
Deaths: 0 deaths
PM Dose Sunitinib Malate
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
3/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
3/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.3%
1/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Peritonitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/30
|
3.3%
1/30
|
|
General disorders
Disease progression
|
3.3%
1/30
|
10.0%
3/30
|
|
General disorders
Asthenia
|
10.0%
3/30
|
0.00%
0/30
|
|
General disorders
General physical health deterioration
|
10.0%
3/30
|
0.00%
0/30
|
|
General disorders
Pyrexia
|
0.00%
0/30
|
6.7%
2/30
|
|
General disorders
Chest pain
|
0.00%
0/30
|
3.3%
1/30
|
|
General disorders
Chills
|
0.00%
0/30
|
3.3%
1/30
|
|
General disorders
Death
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Fatigue
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Hernia pain
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Wound infection
|
3.3%
1/30
|
3.3%
1/30
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Sepsis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Septic shock
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
3.3%
1/30
|
0.00%
0/30
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.3%
1/30
|
0.00%
0/30
|
|
Investigations
Weight decreased
|
0.00%
0/30
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Cachexia
|
3.3%
1/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/30
|
3.3%
1/30
|
|
Nervous system disorders
Syncope
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Confusional state
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30
|
0.00%
0/30
|
Other adverse events
| Measure |
AM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
PM Dose Sunitinib Malate
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
15/30
|
46.7%
14/30
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
9/30
|
30.0%
9/30
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.3%
7/30
|
20.0%
6/30
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
4/30
|
6.7%
2/30
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.3%
1/30
|
0.00%
0/30
|
|
Blood and lymphatic system disorders
Macrocytosis
|
3.3%
1/30
|
0.00%
0/30
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/30
|
3.3%
1/30
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30
|
0.00%
0/30
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30
|
6.7%
2/30
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
2/30
|
3.3%
1/30
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
4/30
|
13.3%
4/30
|
|
Endocrine disorders
Hyperthyroidism
|
3.3%
1/30
|
3.3%
1/30
|
|
Eye disorders
Eyelash discolouration
|
3.3%
1/30
|
10.0%
3/30
|
|
Eye disorders
Conjunctival haemorrhage
|
3.3%
1/30
|
0.00%
0/30
|
|
Eye disorders
Conjunctivitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Eye disorders
Diplopia
|
3.3%
1/30
|
0.00%
0/30
|
|
Eye disorders
Eye pruritus
|
0.00%
0/30
|
3.3%
1/30
|
|
Eye disorders
Eye swelling
|
3.3%
1/30
|
0.00%
0/30
|
|
Eye disorders
Eyelid oedema
|
3.3%
1/30
|
0.00%
0/30
|
|
Eye disorders
Vision blurred
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Diarrhoea
|
56.7%
17/30
|
33.3%
10/30
|
|
Gastrointestinal disorders
Abdominal pain
|
36.7%
11/30
|
43.3%
13/30
|
|
Gastrointestinal disorders
Nausea
|
36.7%
11/30
|
33.3%
10/30
|
|
Gastrointestinal disorders
Vomiting
|
46.7%
14/30
|
23.3%
7/30
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
5/30
|
26.7%
8/30
|
|
Gastrointestinal disorders
Constipation
|
26.7%
8/30
|
16.7%
5/30
|
|
Gastrointestinal disorders
Stomatitis
|
23.3%
7/30
|
20.0%
6/30
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.3%
4/30
|
13.3%
4/30
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
3/30
|
6.7%
2/30
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30
|
6.7%
2/30
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
2/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/30
|
10.0%
3/30
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
1/30
|
6.7%
2/30
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
1/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.3%
1/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gingival bleeding
|
6.7%
2/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Gingival pain
|
3.3%
1/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Glossodynia
|
6.7%
2/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/30
|
6.7%
2/30
|
|
Gastrointestinal disorders
Toothache
|
3.3%
1/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Anal fissure
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Anal pruritus
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Ascites
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Cheilitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Faeces discoloured
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Food poisoning
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Peritonitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Stomach discomfort
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Subileus
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Tongue ulceration
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Asthenia
|
43.3%
13/30
|
33.3%
10/30
|
|
General disorders
Fatigue
|
40.0%
12/30
|
33.3%
10/30
|
|
General disorders
Mucosal inflammation
|
10.0%
3/30
|
26.7%
8/30
|
|
General disorders
Oedema peripheral
|
26.7%
8/30
|
10.0%
3/30
|
|
General disorders
Pyrexia
|
16.7%
5/30
|
20.0%
6/30
|
|
General disorders
Chills
|
10.0%
3/30
|
13.3%
4/30
|
|
General disorders
Chest pain
|
3.3%
1/30
|
13.3%
4/30
|
|
General disorders
General physical health deterioration
|
16.7%
5/30
|
0.00%
0/30
|
|
General disorders
Disease progression
|
3.3%
1/30
|
10.0%
3/30
|
|
General disorders
Pain
|
0.00%
0/30
|
10.0%
3/30
|
|
General disorders
Death
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Face oedema
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Feeling hot
|
0.00%
0/30
|
3.3%
1/30
|
|
General disorders
Hernia pain
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Temperature intolerance
|
3.3%
1/30
|
0.00%
0/30
|
|
Hepatobiliary disorders
Liver disorder
|
3.3%
1/30
|
3.3%
1/30
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
3/30
|
3.3%
1/30
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30
|
6.7%
2/30
|
|
Infections and infestations
Herpes zoster
|
3.3%
1/30
|
3.3%
1/30
|
|
Infections and infestations
Wound infection
|
3.3%
1/30
|
3.3%
1/30
|
|
Infections and infestations
Bronchitis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Folliculitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Incision site cellulitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Laryngitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Sepsis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Septic shock
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Tooth infection
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
1/30
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/30
|
3.3%
1/30
|
|
Investigations
Blood thyroid stimulating hormone increased
|
16.7%
5/30
|
13.3%
4/30
|
|
Investigations
Weight decreased
|
6.7%
2/30
|
13.3%
4/30
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
3/30
|
6.7%
2/30
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30
|
6.7%
2/30
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
3/30
|
3.3%
1/30
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30
|
6.7%
2/30
|
|
Investigations
Blood creatinine increased
|
6.7%
2/30
|
0.00%
0/30
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/30
|
3.3%
1/30
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/30
|
3.3%
1/30
|
|
Investigations
Blood potassium decreased
|
3.3%
1/30
|
0.00%
0/30
|
|
Investigations
Blood urea increased
|
3.3%
1/30
|
0.00%
0/30
|
|
Investigations
Breath sounds absent
|
0.00%
0/30
|
3.3%
1/30
|
|
Investigations
Mean cell haemoglobin increased
|
3.3%
1/30
|
0.00%
0/30
|
|
Investigations
Mean cell volume abnormal
|
3.3%
1/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
8/30
|
23.3%
7/30
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
3/30
|
16.7%
5/30
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
2/30
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
2/30
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.3%
1/30
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Cachexia
|
3.3%
1/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/30
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
1/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
1/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.3%
7/30
|
20.0%
6/30
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.0%
9/30
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
5/30
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.3%
4/30
|
10.0%
3/30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
3/30
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30
|
10.0%
3/30
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
2/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
3.3%
1/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Nodule on extremity
|
3.3%
1/30
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Headache
|
26.7%
8/30
|
20.0%
6/30
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30
|
6.7%
2/30
|
|
Nervous system disorders
Ageusia
|
6.7%
2/30
|
3.3%
1/30
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30
|
3.3%
1/30
|
|
Nervous system disorders
Hyperaesthesia
|
3.3%
1/30
|
3.3%
1/30
|
|
Nervous system disorders
Hypogeusia
|
6.7%
2/30
|
0.00%
0/30
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
2/30
|
0.00%
0/30
|
|
Nervous system disorders
Paraesthesia
|
3.3%
1/30
|
3.3%
1/30
|
|
Nervous system disorders
Amnesia
|
0.00%
0/30
|
3.3%
1/30
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/30
|
3.3%
1/30
|
|
Nervous system disorders
Formication
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Psychomotor skills impaired
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Syncope
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/30
|
3.3%
1/30
|
|
Nervous system disorders
Tremor
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Depression
|
10.0%
3/30
|
6.7%
2/30
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30
|
3.3%
1/30
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30
|
6.7%
2/30
|
|
Psychiatric disorders
Confusional state
|
3.3%
1/30
|
0.00%
0/30
|
|
Renal and urinary disorders
Dysuria
|
3.3%
1/30
|
6.7%
2/30
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
1/30
|
6.7%
2/30
|
|
Renal and urinary disorders
Renal impairment
|
3.3%
1/30
|
3.3%
1/30
|
|
Renal and urinary disorders
Renal pain
|
6.7%
2/30
|
0.00%
0/30
|
|
Renal and urinary disorders
Urinary tract disorder
|
3.3%
1/30
|
3.3%
1/30
|
|
Renal and urinary disorders
Haematuria
|
3.3%
1/30
|
0.00%
0/30
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/30
|
3.3%
1/30
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30
|
3.3%
1/30
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/30
|
3.3%
1/30
|
|
Renal and urinary disorders
Urinary incontinence
|
3.3%
1/30
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Breast pain
|
3.3%
1/30
|
3.3%
1/30
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.7%
2/30
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.3%
1/30
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Metrorrhagia
|
3.3%
1/30
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/30
|
3.3%
1/30
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
3.3%
1/30
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/30
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.3%
7/30
|
16.7%
5/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
3/30
|
13.3%
4/30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30
|
16.7%
5/30
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.3%
1/30
|
6.7%
2/30
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/30
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/30
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/30
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
26.7%
8/30
|
23.3%
7/30
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
23.3%
7/30
|
20.0%
6/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
6/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.3%
1/30
|
16.7%
5/30
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
10.0%
3/30
|
10.0%
3/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
1/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.3%
1/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.7%
2/30
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
1/30
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/30
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
1/30
|
0.00%
0/30
|
|
Surgical and medical procedures
Sinus operation
|
3.3%
1/30
|
0.00%
0/30
|
|
Vascular disorders
Hypertension
|
33.3%
10/30
|
26.7%
8/30
|
|
Vascular disorders
Capillary fragility
|
0.00%
0/30
|
3.3%
1/30
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/30
|
3.3%
1/30
|
|
Vascular disorders
Pallor
|
0.00%
0/30
|
3.3%
1/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosure, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER