Trial Outcomes & Findings for Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer (NCT NCT00471276)
NCT ID: NCT00471276
Last Updated: 2011-07-25
Results Overview
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
COMPLETED
PHASE2
83 participants
Baseline, Week 9, and every 8 weeks up to Month 34
2011-07-25
Participant Flow
Participant milestones
| Measure |
Sunitinib
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
83
|
Reasons for withdrawal
| Measure |
Sunitinib
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Objective progression or relapse
|
54
|
|
Overall Study
Global deterioration of health status
|
1
|
|
Overall Study
Other
|
3
|
|
Overall Study
Refused treatment
|
6
|
Baseline Characteristics
Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib
n=83 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Age Continuous
|
57.5 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 9, and every 8 weeks up to Month 34Population: Intent to Treat (ITT) population: all enrolled participants
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
Sunitinib
n=83 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Number of Participants With Objective Response
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 9, and every 8 weeks up to Month 34Population: ITT
The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (\>) 6 months according to RECIST. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.
Outcome measures
| Measure |
Sunitinib
n=83 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Number of Participants With Clinical Benefit
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 34Population: ITT; Number of participants analyzed equaled (N =) participants who had superficial lesions with post baseline follow-up assessments of those lesions.
Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST. Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.
Outcome measures
| Measure |
Sunitinib
n=15 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Number of Participants With Objective Response of Superficial Lesions
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 34Population: ITT
Time from date of randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months)=(first event date minus randomization date plus 1) divided by 30.4.
Outcome measures
| Measure |
Sunitinib
n=83 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Progression-Free Survival (PFS)
|
3.6 Months
Interval 2.4 to 3.9
|
SECONDARY outcome
Timeframe: Baseline up to Month 34 or early terminationPopulation: ITT; N=participants with objective response
Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first. DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.
Outcome measures
| Measure |
Sunitinib
n=7 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Duration of Response (DR)
|
3.4 Weeks
Interval 1.9 to 12.9
|
SECONDARY outcome
Timeframe: Baseline until death (up to Month 34)Population: ITT
Time from randomization to date of death due to any cause. OS (Months)=(death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.
Outcome measures
| Measure |
Sunitinib
n=83 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Overall Survival (OS)
|
15.6 Months
Interval 14.0 to 22.7
|
SECONDARY outcome
Timeframe: Baseline, Week 9, and every 8 weeks up to Month 34Population: ITT; N=participants who received at least 2 lines of prior chemotherapy for advanced/metastatic disease and had post baseline tumor assessment
Number of participants with objective response based assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
Sunitinib
n=3 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=76 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Week 4 (Cycle 2/Day 1) (n=64)
|
0.0 Units on a scale
Interval -83.0 to 100.0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Month 2 (Cycle 3/Day 1) (n=44)
|
-8.3 Units on a scale
Interval -67.0 to 75.0
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Month 3 (Cycle 4/Day 1) (n=34)
|
-16.7 Units on a scale
Interval -75.0 to 66.7
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Month 4 (Cycle 5/Day 1) (n=19)
|
-8.3 Units on a scale
Interval -67.0 to 66.7
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Month 5 (Cycle 6/Day 1) (n=16)
|
-8.3 Units on a scale
Interval -42.0 to 33.3
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Baseline (Cycle 1/Day 1) (n=76)
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=77 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Week 4 (Cycle 2/Day 1) (n=60)
|
0.0 Units on a scale
Interval -42.0 to 66.7
|
|
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Month 2 (Cycle 3/Day 1) (n=38)
|
0.0 Units on a scale
Interval -33.0 to 91.7
|
|
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Month 3 (Cycle 4/Day 1) (n=29)
|
0.0 Units on a scale
Interval -75.0 to 91.7
|
|
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Month 4 (Cycle 5/Day 1) (n=17)
|
0.0 Units on a scale
Interval -33.0 to 16.7
|
|
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Month 5 (Cycle 6/Day 1) (n=14)
|
0.0 Units on a scale
Interval -42.0 to 8.33
|
|
Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Baseline (Cycle 1/Day 1) (n=77)
|
83.3 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=76 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Week 4 (Cycle 2/Day 1) (n=59)
|
0.0 Units on a scale
Interval -100.0 to 66.7
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Month 2 (Cycle 3/Day 1) (n=38)
|
-33.3 Units on a scale
Interval -100.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Month 3 (Cycle 4/Day 1) (n=29)
|
-33.3 Units on a scale
Interval -100.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Month 4 (Cycle 5/Day 1) (n=17)
|
0.0 Units on a scale
Interval -67.0 to 0.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Month 5 (Cycle 6/Day 1) (n=14)
|
-16.7 Units on a scale
Interval -67.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Baseline (Cycle 1/Day 1) (n=76)
|
66.7 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=32 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Week 4 (Cycle 2/Day 1) (n=17)
|
0.0 Units on a scale
Interval -33.0 to 100.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Month 2 (Cycle 3/Day 1) (n=10)
|
0.0 Units on a scale
Interval -33.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Month 3 (Cycle 4/Day 1) (n=6)
|
0.0 Units on a scale
Interval -67.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Month 4 (Cycle 5/Day 1) (n=5)
|
0.0 Units on a scale
Interval 0.0 to 66.7
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Month 5 (Cycle 6/Day 1) (n=4)
|
0.0 Units on a scale
Interval 0.0 to 100.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Baseline (Cycle 1/Day 1) (n=32)
|
33.3 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=72 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Week 4 (Cycle 2/Day 1) (n=56)
|
0.0 Units on a scale
Interval -33.0 to 100.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Month 2 (Cycle 3/Day 1) (n=36)
|
0.0 Units on a scale
Interval -83.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Month 3 (Cycle 4/Day 1) (n=25)
|
0.0 Units on a scale
Interval -100.0 to 16.7
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Month 4 (Cycle 5/Day 1) (n=15)
|
0.0 Units on a scale
Interval -33.0 to 0.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Month 5 (Cycle 6/Day 1) (n=12)
|
0.0 Units on a scale
Interval -33.0 to 0.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Baseline (Cycle 1/Day 1) (n=72)
|
100.0 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=77 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Week 4 (Cycle 2/Day 1) (n=62)
|
0.0 Units on a scale
Interval -67.0 to 44.4
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Month 2 (Cycle 3/Day 1) (n=40)
|
0.0 Units on a scale
Interval -67.0 to 44.4
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Month 3 (Cycle 4/Day 1) (n=30)
|
0.0 Units on a scale
Interval -67.0 to 44.4
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Month 4 (Cycle 5/Day 1) (n=17)
|
0.0 Units on a scale
Interval -67.0 to 66.7
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Month 5 (Cycle 6/Day 1) (n=14)
|
0.0 Units on a scale
Interval -67.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Baseline (Cycle 1/Day 1) (n=77)
|
11.1 Units on a scale
Interval 0.0 to 77.8
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=76 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Month 4 (Cycle 5/Day 1) (n=17)
|
0.0 Units on a scale
Interval -50.0 to 13.9
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Week 4 (Cycle 2/Day 1) (n=61)
|
0.0 Units on a scale
Interval -42.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Month 2 (Cycle 3/Day 1) (n=39)
|
0.0 Units on a scale
Interval -42.0 to 16.7
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Month 3 (Cycle 4/Day 1) (n=30)
|
0.0 Units on a scale
Interval -50.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Month 5 (Cycle 6/Day 1) (n=14)
|
0.0 Units on a scale
Interval -42.0 to 8.33
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Baseline (Cycle 1/Day 1) (n=76)
|
8.3 Units on a scale
Interval 0.0 to 83.3
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=77 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Week 4 (Cycle 2/Day 1) (n=62)
|
14.3 Units on a scale
Interval -24.0 to 57.1
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Month 2 (Cycle 3/Day 1) (n=40)
|
19.0 Units on a scale
Interval -24.0 to 52.4
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Month 3 (Cycle 4/Day 1) (n=29)
|
14.3 Units on a scale
Interval -14.0 to 57.1
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Month 4 (Cycle 5/Day 1) (n=17)
|
23.8 Units on a scale
Interval -4.8 to 61.9
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Month 5 (Cycle 6/Day 1) (n=14)
|
19.0 Units on a scale
Interval 4.76 to 42.9
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Baseline (Cycle 1/Day 1) (n=77)
|
14.3 Units on a scale
Interval 0.0 to 76.2
|
SECONDARY outcome
Timeframe: Baseline, every 4 weeks up to Month 31 or early terminationPopulation: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.
EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=25 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Week 4 (Cycle 2/Day 1) (n=5)
|
0.0 Units on a scale
Interval -33.0 to 33.3
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Month 2 (Cycle 3/Day 1) (n=8)
|
0.0 Units on a scale
Interval 0.0 to 0.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Month 3 (Cycle 4/Day 1) (n=6)
|
0.0 Units on a scale
Interval 0.0 to 100.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Month 4 (Cycle 5/Day 1) (n=5)
|
0.0 Units on a scale
Interval 0.0 to 100.0
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Month 5 (Cycle 6/Day 1) (n=4)
|
0.0 Units on a scale
Interval 0.0 to 66.7
|
|
Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Baseline (Cycle 1/Day 1) (n=25)
|
0.0 Units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early terminationPopulation: ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.
CTSQ: included 3 multi-item subscales (Expectation of Therapy \[ET\], Satisfaction with Therapy \[SWT\], and Feelings about Side Effects \[FSE\]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=59 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Baseline (Cycle 1/Day 1) (n=59)
|
70.00 Units on a scale
Interval 0.0 to 100.0
|
|
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Cycle 1/Day 15 (n=2)
|
20.00 Units on a scale
Interval 10.0 to 30.0
|
|
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Week 4 (Cycle 2/Day 1) (n=48)
|
0.00 Units on a scale
Interval -35.0 to 75.0
|
|
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Week 8 (Cycle 3/Day 1) (n=31)
|
5.00 Units on a scale
Interval -50.0 to 75.0
|
|
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Month 4 (Cycle 5/Day 1) (n=11)
|
5.00 Units on a scale
Interval -30.0 to 35.0
|
|
Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Month 6 (Cycle 7/Day 1) (n=2)
|
17.50 Units on a scale
Interval 0.0 to 35.0
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early terminationPopulation: ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.
CTSQ: included 3 multi-item subscales (Expectation of Therapy \[ET\], Satisfaction with Therapy \[SWT\], and Feelings about Side Effects \[FSE\]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=58 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in CTSQ Score: Feelings About Side Effects
Cycle 1/Day 15 (n=2)
|
3.13 Units on a scale
Interval -12.5 to 18.75
|
|
Change From Baseline in CTSQ Score: Feelings About Side Effects
Week 4 (Cycle 2/Day 1) (n=47)
|
0.00 Units on a scale
Interval -56.3 to 75.0
|
|
Change From Baseline in CTSQ Score: Feelings About Side Effects
Week 8 (Cycle 3/Day 1) (n=31)
|
0.00 Units on a scale
Interval -62.5 to 75.0
|
|
Change From Baseline in CTSQ Score: Feelings About Side Effects
Month 4 (Cycle 5/Day 1) (n=12)
|
0.00 Units on a scale
Interval -56.3 to 75.0
|
|
Change From Baseline in CTSQ Score: Feelings About Side Effects
Month 6 (Cycle 7/Day 1) (n=2)
|
-6.25 Units on a scale
Interval -18.8 to 6.25
|
|
Change From Baseline in CTSQ Score: Feelings About Side Effects
Baseline (Cycle 1/Day 1) (n=58)
|
62.50 Units on a scale
Interval 12.5 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early terminationPopulation: ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.
CTSQ: included 3 multi-item subscales (Expectation of Therapy \[ET\], Satisfaction with Therapy \[SWT\], and Feelings about Side Effects \[FSE\]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.
Outcome measures
| Measure |
Sunitinib
n=59 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Week 8 (Cycle 3/Day 1) (n=31)
|
7.14 Units on a scale
Interval -58.9 to 60.71
|
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Cycle 1/Day 15 (n=2)
|
8.93 Units on a scale
Interval 0.0 to 17.86
|
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Week 4 (Cycle 2/Day 1) (n=48)
|
10.71 Units on a scale
Interval -35.7 to 53.57
|
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Month 4 (Cycle 5/Day 1) (n=12)
|
11.79 Units on a scale
Interval -32.1 to 57.14
|
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Month 6 (Cycle 7/Day 1) (n=2)
|
-1.79 Units on a scale
Interval -3.57 to 0.0
|
|
Change From Baseline in CTSQ Score: Satisfaction With Therapy
Baseline (Cycle 1/Day 1) (n=59)
|
71.43 Units on a scale
Interval 25.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 1 yearPopulation: ITT
Probability of survival 1 year after the first dose of study treatment.
Outcome measures
| Measure |
Sunitinib
n=83 Participants
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
1-Year Survival Probability
|
65.0 Percentage of participants
Interval 54.5 to 75.4
|
Adverse Events
Sunitinib
Serious adverse events
| Measure |
Sunitinib
n=83 participants at risk
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
3/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
2.4%
2/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
2.4%
2/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Confusional state
|
2.4%
2/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
2.4%
2/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
2.4%
2/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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 failure congestive
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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.
|
|
Endocrine disorders
Hypothyroidism
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Diarrhea
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Gastrointestinal Haemorrhage
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Hyperbilirubinaemia
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Anal abscess
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Failure to thrive
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Aphasia
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Ataxia
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Pleural effusion
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Deep vein thrombosis
|
1.2%
1/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
| Measure |
Sunitinib
n=83 participants at risk
Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
20/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Leukopenia
|
39.8%
33/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
44.6%
37/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
41.0%
34/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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.
|
|
Endocrine disorders
Hypothyroidism
|
9.6%
8/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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.
|
|
Eye disorders
Lacrimation increased
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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.
|
|
Eye disorders
Vision blurred
|
8.4%
7/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
14.5%
12/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
53.0%
44/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Dry mouth
|
12.0%
10/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
16.9%
14/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Gastrooesophageal reflux disease
|
10.8%
9/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
48.2%
40/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
14.5%
12/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
18.1%
15/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
32.5%
27/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
10.8%
9/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
60.2%
50/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Mucosal inflammation
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Urinary tract infection
|
14.5%
12/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Contusion
|
8.4%
7/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Alanine aminotransferase increased
|
9.6%
8/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Aspartate aminotransferase increased
|
12.0%
10/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Blood alkaline phosphatase increased
|
8.4%
7/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Blood creatinine increased
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Weight decreased
|
10.8%
9/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
43.4%
36/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Dehydration
|
15.7%
13/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
15.7%
13/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
18.1%
15/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Back pain
|
13.3%
11/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
12.0%
10/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Muscular weakness
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
7.2%
6/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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 pain
|
7.2%
6/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Pain in extremity
|
12.0%
10/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Dizziness
|
10.8%
9/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
31.3%
26/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
16.9%
14/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Insomnia
|
12.0%
10/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
16.9%
14/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
13.3%
11/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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 exertional
|
8.4%
7/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
7.2%
6/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Acne
|
8.4%
7/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Alopecia
|
8.4%
7/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
10.8%
9/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Hair colour changes
|
7.2%
6/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Nail disorder
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Palmar-plantar erythrodysaesthesia syndrome
|
20.5%
17/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Pruritus
|
10.8%
9/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
16.9%
14/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Skin discolouration
|
6.0%
5/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
Yellow skin
|
13.3%
11/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
|
25.3%
21/83
The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been 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
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