Trial Outcomes & Findings for Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma (NCT NCT00076011)
NCT ID: NCT00076011
Last Updated: 2012-06-26
Results Overview
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks
Results posted on
2012-06-26
Participant Flow
Participant milestones
| Measure |
Axitinib
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Axitinib
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Lack of Efficacy
|
25
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study terminated by sponsor
|
3
|
|
Overall Study
Other
|
11
|
|
Overall Study
Ongoing
|
1
|
Baseline Characteristics
Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Axitinib
n=52 Participants
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Age Continuous
|
58.8 Years
STANDARD_DEVIATION 11.25 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeksPopulation: Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
Axitinib
n=52 Participants
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Percentage of Participants With Objective Response (OR)
|
44.2 Percentage of participants
Interval 30.5 to 58.7
|
SECONDARY outcome
Timeframe: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeksPopulation: Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.
Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).
Outcome measures
| Measure |
Axitinib
n=52 Participants
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Time to Disease Progression (TTP)
|
477.0 Days
Interval 255.0 to 712.0
|
SECONDARY outcome
Timeframe: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeksPopulation: Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Outcome measures
| Measure |
Axitinib
n=23 Participants
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Duration of Response (DR)
|
700.0 Days
Interval 635.0 to
The upper limit of 95% confidence interval (CI) was not estimable due to the high number of participants censored.
|
SECONDARY outcome
Timeframe: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participantPopulation: Study population included all participants who received at least 1 dose of study medication.
Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
Outcome measures
| Measure |
Axitinib
n=52 Participants
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Overall Survival (OS)
|
911.0 Days
Interval 619.0 to
The upper limit of 95% CI was not estimable due to the high number of participants censored for survival.
|
SECONDARY outcome
Timeframe: Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dosePopulation: Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, 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 |
Axitinib
n=52 Participants
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 505 (n=20)
|
-6.7 Units on a scale
Standard Deviation 29.32
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 729 (n=11)
|
8.3 Units on a scale
Standard Deviation 25.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 729 (n=11)
|
4.5 Units on a scale
Standard Deviation 36.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 841 (n=4)
|
4.2 Units on a scale
Standard Deviation 20.97
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 393 (n=19)
|
-4.1 Units on a scale
Standard Deviation 22.59
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 449 (n=17)
|
-0.0 Units on a scale
Standard Deviation 26.64
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 505 (n=20)
|
4.7 Units on a scale
Standard Deviation 25.44
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 169 (n=32)
|
1.0 Units on a scale
Standard Deviation 15.80
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 337 (n=14)
|
4.8 Units on a scale
Standard Deviation 25.68
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 393 (n=18)
|
-7.4 Units on a scale
Standard Deviation 21.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 449 (n=17)
|
0.0 Units on a scale
Standard Deviation 26.35
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 953 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 169 (n=32)
|
16.7 Units on a scale
Standard Deviation 38.80
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 225 (n=28)
|
20.2 Units on a scale
Standard Deviation 26.20
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 281 (n=23)
|
29.0 Units on a scale
Standard Deviation 28.96
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 673 (n=11)
|
36.4 Units on a scale
Standard Deviation 37.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 729 (n=11)
|
27.3 Units on a scale
Standard Deviation 32.72
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 785 (n=10)
|
16.7 Units on a scale
Standard Deviation 17.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 841 (n=5)
|
20.0 Units on a scale
Standard Deviation 18.26
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 225 (n=28)
|
1.2 Units on a scale
Standard Deviation 32.05
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 281 (n=23)
|
1.4 Units on a scale
Standard Deviation 15.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 449 (n=16)
|
2.1 Units on a scale
Standard Deviation 22.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 729 (n=11)
|
-6.1 Units on a scale
Standard Deviation 25.03
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 785 (n=10)
|
10.0 Units on a scale
Standard Deviation 31.62
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 841 (n=4)
|
8.3 Units on a scale
Standard Deviation 16.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 953 (n=1)
|
-66.7 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Baseline (n=52)
|
68.9 Units on a scale
Standard Deviation 23.05
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 29 (n=46)
|
-6.0 Units on a scale
Standard Deviation 20.54
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 57 (n=33)
|
-0.3 Units on a scale
Standard Deviation 24.60
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 113 (n=41)
|
-4.9 Units on a scale
Standard Deviation 25.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 169 (n=32)
|
-7.6 Units on a scale
Standard Deviation 28.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 225 (n=28)
|
4.8 Units on a scale
Standard Deviation 29.17
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 281 (n=22)
|
2.3 Units on a scale
Standard Deviation 24.42
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 337 (n=14)
|
-0.6 Units on a scale
Standard Deviation 26.65
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 393 (n=19)
|
5.7 Units on a scale
Standard Deviation 24.85
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 449 (n=16)
|
6.3 Units on a scale
Standard Deviation 28.30
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 505 (n=19)
|
1.8 Units on a scale
Standard Deviation 30.75
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 561 (n=16)
|
2.6 Units on a scale
Standard Deviation 31.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 617 (n=14)
|
-6.0 Units on a scale
Standard Deviation 34.35
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 673 (n=11)
|
5.3 Units on a scale
Standard Deviation 34.01
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 729 (n=11)
|
8.3 Units on a scale
Standard Deviation 28.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 785 (n=10)
|
9.2 Units on a scale
Standard Deviation 36.74
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 841 (n=4)
|
-8.3 Units on a scale
Standard Deviation 29.66
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 897 (n=1)
|
-16.7 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at Day 953 (n=1)
|
-33.3 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Global health status: Change at follow-up (n=12)
|
-0.7 Units on a scale
Standard Deviation 17.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Baseline (n=52 )
|
80.6 Units on a scale
Standard Deviation 18.84
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 29 (n=47)
|
-7.1 Units on a scale
Standard Deviation 16.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 57 (n=45)
|
-2.6 Units on a scale
Standard Deviation 15.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 113 (n=41)
|
-3.8 Units on a scale
Standard Deviation 15.38
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 169 (n=32)
|
-5.9 Units on a scale
Standard Deviation 14.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 225 (n=28)
|
-3.6 Units on a scale
Standard Deviation 17.11
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 281 (n=23)
|
-2.7 Units on a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 337 (n=14)
|
-1.0 Units on a scale
Standard Deviation 18.09
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 393 (n=19)
|
1.8 Units on a scale
Standard Deviation 12.93
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 449 (n=17)
|
-3.0 Units on a scale
Standard Deviation 18.45
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 505 (n=20)
|
-3.0 Units on a scale
Standard Deviation 18.29
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 561 (n=17)
|
-6.3 Units on a scale
Standard Deviation 21.79
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 617 (n=14)
|
-3.8 Units on a scale
Standard Deviation 20.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 673 (n=11)
|
4.2 Units on a scale
Standard Deviation 15.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 729 (n=11)
|
4.2 Units on a scale
Standard Deviation 18.44
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 785 (n=10)
|
-3.3 Units on a scale
Standard Deviation 19.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 841 (n=5)
|
6.7 Units on a scale
Standard Deviation 16.33
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at Day 953 (n=1)
|
-33.3 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Physical functioning: Change at follow-up (n=12)
|
-6.8 Units on a scale
Standard Deviation 17.53
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Baseline (n=52 )
|
80.4 Units on a scale
Standard Deviation 26.55
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 29 (n=47)
|
-9.2 Units on a scale
Standard Deviation 28.62
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 57 (n=45)
|
-8.9 Units on a scale
Standard Deviation 22.64
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 113 (n=41)
|
-13.4 Units on a scale
Standard Deviation 32.32
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 169 (n=32)
|
-14.6 Units on a scale
Standard Deviation 25.66
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 225 (n=28)
|
-8.9 Units on a scale
Standard Deviation 31.26
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 281 (n=23)
|
-5.8 Units on a scale
Standard Deviation 23.36
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 337 (n=14)
|
-6.0 Units on a scale
Standard Deviation 19.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 393 (n=19)
|
-2.6 Units on a scale
Standard Deviation 23.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 449 (n=16)
|
-4.2 Units on a scale
Standard Deviation 34.69
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 561 (n=17)
|
-9.8 Units on a scale
Standard Deviation 32.84
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 617 (n=14)
|
-13.1 Units on a scale
Standard Deviation 32.14
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 673 (n=11)
|
-4.5 Units on a scale
Standard Deviation 27.98
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 729 (n=11)
|
1.5 Units on a scale
Standard Deviation 31.14
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 785 (n=10)
|
-6.7 Units on a scale
Standard Deviation 32.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 841 (n=5)
|
10.0 Units on a scale
Standard Deviation 27.89
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at Day 953 (n=1)
|
-33.3 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Role functioning: Change at follow-up (n=12)
|
-11.1 Units on a scale
Standard Deviation 22.84
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Baseline (n=52)
|
80.1 Units on a scale
Standard Deviation 19.40
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 29 (n=46)
|
-0.4 Units on a scale
Standard Deviation 19.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 57 (n=33)
|
3.8 Units on a scale
Standard Deviation 16.55
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 113 (n=41)
|
-0.2 Units on a scale
Standard Deviation 15.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 169 (n=32)
|
-0.3 Units on a scale
Standard Deviation 16.86
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 225 (n=28)
|
6.5 Units on a scale
Standard Deviation 22.26
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 281 (n=23)
|
6.5 Units on a scale
Standard Deviation 17.40
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 337 (n=14)
|
11.3 Units on a scale
Standard Deviation 19.78
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 393 (n=19)
|
11.0 Units on a scale
Standard Deviation 17.36
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 449 (n=16)
|
7.5 Units on a scale
Standard Deviation 23.69
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 505 (n=19)
|
4.4 Units on a scale
Standard Deviation 21.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 561 (n=17)
|
7.5 Units on a scale
Standard Deviation 21.17
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 617 (n=14)
|
6.5 Units on a scale
Standard Deviation 21.23
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 673 (n=11)
|
9.1 Units on a scale
Standard Deviation 24.28
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 785 (n=10)
|
4.2 Units on a scale
Standard Deviation 20.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 841 (n=4)
|
6.3 Units on a scale
Standard Deviation 21.92
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 897 (n=1)
|
25.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at Day 953 (n=1)
|
-16.7 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Emotional functioning: Change at follow-up (n=12)
|
-3.5 Units on a scale
Standard Deviation 20.86
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Baseline (n=52)
|
86.5 Units on a scale
Standard Deviation 16.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 29 (n=46)
|
-2.5 Units on a scale
Standard Deviation 16.47
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 57 (n=33)
|
1.0 Units on a scale
Standard Deviation 14.40
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 113 (n=41)
|
-5.3 Units on a scale
Standard Deviation 15.11
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 169 (n=32)
|
-7.8 Units on a scale
Standard Deviation 15.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 225 (n=28)
|
-6.5 Units on a scale
Standard Deviation 19.95
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 281 (n=23)
|
-2.2 Units on a scale
Standard Deviation 14.48
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 337 (n=14)
|
0.0 Units on a scale
Standard Deviation 20.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 393 (n=19)
|
0.9 Units on a scale
Standard Deviation 17.10
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 449 (n=16)
|
0.0 Units on a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 505 (n=19)
|
-0.9 Units on a scale
Standard Deviation 15.19
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 561 (n=17)
|
-1.0 Units on a scale
Standard Deviation 19.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 617 (n=14)
|
-4.8 Units on a scale
Standard Deviation 18.98
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 673 (n=11)
|
1.5 Units on a scale
Standard Deviation 21.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 729 (n=11)
|
3.0 Units on a scale
Standard Deviation 22.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 785 (n=10)
|
0.0 Units on a scale
Standard Deviation 17.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 841 (n=4)
|
0.0 Units on a scale
Standard Deviation 27.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at Day 953 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Cognitive Functioning: Change at follow-up (n=12)
|
-4.2 Units on a scale
Standard Deviation 16.09
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Baseline (n=52)
|
81.7 Units on a scale
Standard Deviation 26.46
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 29 (n=46)
|
-8.7 Units on a scale
Standard Deviation 29.97
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 57 (n=33)
|
-3.0 Units on a scale
Standard Deviation 31.31
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 113 (n=41)
|
-6.1 Units on a scale
Standard Deviation 27.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 169 (n=32)
|
-9.4 Units on a scale
Standard Deviation 31.09
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 225 (n=28)
|
-1.2 Units on a scale
Standard Deviation 38.74
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 281 (n=23)
|
4.3 Units on a scale
Standard Deviation 28.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 337 (n=14)
|
-0.0 Units on a scale
Standard Deviation 35.20
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 393 (n=19)
|
1.8 Units on a scale
Standard Deviation 26.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 449 (n=16)
|
-3.1 Units on a scale
Standard Deviation 30.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 505 (n=19)
|
-3.5 Units on a scale
Standard Deviation 35.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 561 (n=17)
|
-6.9 Units on a scale
Standard Deviation 33.88
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 617 (n=14)
|
-9.5 Units on a scale
Standard Deviation 32.50
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 673 (n=11)
|
4.5 Units on a scale
Standard Deviation 35.03
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at Day 785 (n=10)
|
1.7 Units on a scale
Standard Deviation 36.39
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Social functioning: Change at follow-up (n=12)
|
-2.8 Units on a scale
Standard Deviation 23.39
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Baseline (n=52)
|
27.4 Units on a scale
Standard Deviation 23.64
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 29 (n=47)
|
11.8 Units on a scale
Standard Deviation 24.54
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 57 (n=45)
|
7.2 Units on a scale
Standard Deviation 22.27
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 113 (n=41)
|
7.2 Units on a scale
Standard Deviation 22.58
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 169 (n=32)
|
6.9 Units on a scale
Standard Deviation 18.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 225 (n=28)
|
3.8 Units on a scale
Standard Deviation 28.37
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 281 (n=23)
|
1.9 Units on a scale
Standard Deviation 24.31
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 337 (n=14)
|
3.2 Units on a scale
Standard Deviation 24.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 561 (n=17)
|
3.3 Units on a scale
Standard Deviation 26.28
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 617 (n=14)
|
8.3 Units on a scale
Standard Deviation 24.92
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 673 (n=11)
|
-3.0 Units on a scale
Standard Deviation 25.38
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 729 (n=11)
|
-4.0 Units on a scale
Standard Deviation 27.79
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 785 (n=10)
|
-1.1 Units on a scale
Standard Deviation 30.74
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 841 (n=5)
|
2.2 Units on a scale
Standard Deviation 21.37
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Day 953 (n=1)
|
66.7 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Fatigue: Change at Follow-up (n=12)
|
5.6 Units on a scale
Standard Deviation 19.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Baseline (n=52)
|
4.8 Units on a scale
Standard Deviation 12.93
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 29 (n=47)
|
1.4 Units on a scale
Standard Deviation 14.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 57 (n=45)
|
4.1 Units on a scale
Standard Deviation 16.34
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 113 (n=41)
|
10.2 Units on a scale
Standard Deviation 19.32
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 785 (n=10)
|
-1.7 Units on a scale
Standard Deviation 26.59
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 841 (n=5)
|
6.7 Units on a scale
Standard Deviation 9.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 225 (n=28)
|
1.2 Units on a scale
Standard Deviation 16.93
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 281 (n=23)
|
-0.7 Units on a scale
Standard Deviation 15.47
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 337 (n=14)
|
1.2 Units on a scale
Standard Deviation 23.99
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 393 (n=19)
|
1.8 Units on a scale
Standard Deviation 22.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 449 (n=17)
|
5.9 Units on a scale
Standard Deviation 22.78
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 505 (n=20)
|
1.7 Units on a scale
Standard Deviation 17.85
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 561 (n=17)
|
4.9 Units on a scale
Standard Deviation 22.64
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 617 (n=14)
|
11.9 Units on a scale
Standard Deviation 15.23
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 673 (n=11)
|
6.1 Units on a scale
Standard Deviation 30.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 729 (n=11)
|
0.0 Units on a scale
Standard Deviation 24.72
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at Day 953 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Nausea and vomiting: Change at follow-up (n=12)
|
1.4 Units on a scale
Standard Deviation 11.14
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Baseline (n=52)
|
22.1 Units on a scale
Standard Deviation 23.04
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 29 (n=47)
|
10.3 Units on a scale
Standard Deviation 22.40
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 57 (n=45)
|
5.9 Units on a scale
Standard Deviation 26.39
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 113 (n=42)
|
6.7 Units on a scale
Standard Deviation 25.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 169 (n=32)
|
5.2 Units on a scale
Standard Deviation 29.77
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 225 (n=29)
|
6.9 Units on a scale
Standard Deviation 35.50
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 281 (n=23)
|
0.7 Units on a scale
Standard Deviation 34.26
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 337 (n=14)
|
-0.0 Units on a scale
Standard Deviation 26.95
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 393 (n=19)
|
-7.0 Units on a scale
Standard Deviation 27.95
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 449 (n=17)
|
-3.9 Units on a scale
Standard Deviation 27.97
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 505 (n=20)
|
6.7 Units on a scale
Standard Deviation 32.17
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 561 (n=17)
|
1.0 Units on a scale
Standard Deviation 32.53
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 617 (n=14)
|
3.6 Units on a scale
Standard Deviation 25.47
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 673 (n=11)
|
-3.0 Units on a scale
Standard Deviation 37.87
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 729 (n=11)
|
-1.5 Units on a scale
Standard Deviation 32.88
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 785 (n=10)
|
3.3 Units on a scale
Standard Deviation 33.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 841 (n=5)
|
-3.3 Units on a scale
Standard Deviation 24.72
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at Day 953 (n=1)
|
33.3 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Pain: Change at follow-up (n=12)
|
8.3 Units on a scale
Standard Deviation 33.71
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Baseline (n=52)
|
18.6 Units on a scale
Standard Deviation 24.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 29 (n=47)
|
-0.7 Units on a scale
Standard Deviation 23.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 505 (n=20)
|
-0.0 Units on a scale
Standard Deviation 34.20
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 57 (n=45)
|
-0.7 Units on a scale
Standard Deviation 19.45
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 113 (n=41)
|
-1.6 Units on a scale
Standard Deviation 18.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 169 (n=32)
|
-3.1 Units on a scale
Standard Deviation 22.97
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 225 (n=28)
|
2.4 Units on a scale
Standard Deviation 29.99
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 281 (n=23)
|
0.0 Units on a scale
Standard Deviation 31.78
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 337 (n=14)
|
-7.1 Units on a scale
Standard Deviation 32.50
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 393 (n=19)
|
-5.3 Units on a scale
Standard Deviation 20.07
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 449 (n=17)
|
-5.9 Units on a scale
Standard Deviation 24.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 505 (n=20)
|
1.7 Units on a scale
Standard Deviation 29.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 561 (n=17)
|
0.0 Units on a scale
Standard Deviation 26.35
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 617 (n=14)
|
4.8 Units on a scale
Standard Deviation 31.64
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 673 (n=11)
|
-6.1 Units on a scale
Standard Deviation 32.72
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 729 (n=11)
|
-3.0 Units on a scale
Standard Deviation 27.71
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 561 (n=17)
|
2.0 Units on a scale
Standard Deviation 36.27
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 617 (n=14)
|
9.5 Units on a scale
Standard Deviation 20.37
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 785 (n=10)
|
3.3 Units on a scale
Standard Deviation 24.60
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 841 (n=5)
|
0.0 Units on a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at Day 953 (n=1)
|
33.3 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Dyspnea: Change at follow-up (n=12)
|
-2.8 Units on a scale
Standard Deviation 22.29
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Baseline (n=51)
|
23.5 Units on a scale
Standard Deviation 30.03
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 673 (n=11)
|
-3.0 Units on a scale
Standard Deviation 43.34
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 29 (n=46)
|
-1.4 Units on a scale
Standard Deviation 30.60
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 57 (n=45)
|
-2.2 Units on a scale
Standard Deviation 30.48
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 113 (n=41)
|
-3.3 Units on a scale
Standard Deviation 28.68
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 169 (n=32)
|
-2.1 Units on a scale
Standard Deviation 31.61
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 225 (n=28)
|
-4.8 Units on a scale
Standard Deviation 38.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 281 (n=23)
|
0.0 Units on a scale
Standard Deviation 36.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 337 (n=14)
|
-7.1 Units on a scale
Standard Deviation 37.39
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 393 (n=19)
|
-7.0 Units on a scale
Standard Deviation 36.14
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 449 (n=17)
|
-2.0 Units on a scale
Standard Deviation 32.21
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 505 (n=20)
|
-5.0 Units on a scale
Standard Deviation 31.11
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 561 (n=17)
|
-9.8 Units on a scale
Standard Deviation 36.83
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 617 (n=14)
|
-4.8 Units on a scale
Standard Deviation 34.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 673 (n=11)
|
-3.0 Units on a scale
Standard Deviation 43.34
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 729 (n=11)
|
-12.1 Units on a scale
Standard Deviation 34.23
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 785 (n=10)
|
-13.3 Units on a scale
Standard Deviation 39.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 841 (n=5)
|
-13.3 Units on a scale
Standard Deviation 50.55
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at Day 953 (n=1)
|
33.3 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Insomnia: Change at follow-up (n=11)
|
-3.0 Units on a scale
Standard Deviation 23.35
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Baseline (n=52)
|
12.8 Units on a scale
Standard Deviation 25.70
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 29 (n=47)
|
7.1 Units on a scale
Standard Deviation 31.80
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 57 (n=45)
|
5.9 Units on a scale
Standard Deviation 33.55
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 113 (n=41)
|
15.4 Units on a scale
Standard Deviation 34.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 169 (n=32)
|
5.2 Units on a scale
Standard Deviation 35.02
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 225 (n=28)
|
4.8 Units on a scale
Standard Deviation 38.18
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 281 (n=22)
|
1.5 Units on a scale
Standard Deviation 31.67
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 337 (n=14)
|
-2.4 Units on a scale
Standard Deviation 42.29
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 393 (n=19)
|
5.3 Units on a scale
Standard Deviation 35.60
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 449 (n=17)
|
2.0 Units on a scale
Standard Deviation 36.27
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 729 (n=11)
|
-6.1 Units on a scale
Standard Deviation 35.96
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 785 (n=10)
|
-13.3 Units on a scale
Standard Deviation 42.16
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 841 (n=5)
|
6.7 Units on a scale
Standard Deviation 43.46
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at Day 953 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Loss of appetite: Change at follow-up (n=12)
|
8.3 Units on a scale
Standard Deviation 25.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Baseline (n=52)
|
13.5 Units on a scale
Standard Deviation 22.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 29 (n=47)
|
5.0 Units on a scale
Standard Deviation 16.99
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 57 (n=45)
|
3.0 Units on a scale
Standard Deviation 17.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 113 (n=41)
|
4.1 Units on a scale
Standard Deviation 27.08
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 169 (n=32)
|
2.1 Units on a scale
Standard Deviation 28.00
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Baseline (n=52)
|
8.3 Units on a scale
Standard Deviation 20.74
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 29 (n=47)
|
1.4 Units on a scale
Standard Deviation 16.96
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 57 (n=45)
|
5.9 Units on a scale
Standard Deviation 21.66
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 225 (n=28)
|
0.0 Units on a scale
Standard Deviation 25.66
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 281 (n=23)
|
2.9 Units on a scale
Standard Deviation 22.28
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 505 (n=20)
|
5.0 Units on a scale
Standard Deviation 29.17
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 561 (n=17)
|
0.0 Units on a scale
Standard Deviation 23.57
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 617 (n=14)
|
-4.8 Units on a scale
Standard Deviation 17.82
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 673 (n=11)
|
-6.1 Units on a scale
Standard Deviation 20.10
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 729 (n=11)
|
-3.0 Units on a scale
Standard Deviation 10.05
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 785 (n=10)
|
-3.3 Units on a scale
Standard Deviation 18.92
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 841 (n=5)
|
-6.7 Units on a scale
Standard Deviation 14.91
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Constipation: Change at follow-up (n=12)
|
2.8 Units on a scale
Standard Deviation 22.29
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 113 (n=41)
|
17.9 Units on a scale
Standard Deviation 28.96
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 337 (n=14)
|
42.9 Units on a scale
Standard Deviation 33.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 393 (n=19)
|
33.3 Units on a scale
Standard Deviation 33.33
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 449 (n=17)
|
23.5 Units on a scale
Standard Deviation 25.72
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 505 (n=20)
|
35.0 Units on a scale
Standard Deviation 35.00
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 561 (n=17)
|
31.4 Units on a scale
Standard Deviation 27.56
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 617 (n=14)
|
40.5 Units on a scale
Standard Deviation 26.73
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at Day 953 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Diarrhea: Change at follow-up (n=12)
|
-11.1 Units on a scale
Standard Deviation 25.95
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Baseline (n=51)
|
15.0 Units on a scale
Standard Deviation 26.09
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 29 (n=45)
|
-3.0 Units on a scale
Standard Deviation 24.44
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 57 (n=33)
|
-8.1 Units on a scale
Standard Deviation 26.39
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 113 (n=41)
|
-5.7 Units on a scale
Standard Deviation 23.45
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 169 (n=32)
|
-3.1 Units on a scale
Standard Deviation 13.01
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 337 (n=14)
|
0.0 Units on a scale
Standard Deviation 18.49
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 393 (n=19)
|
-1.8 Units on a scale
Standard Deviation 20.71
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 505 (n=19)
|
-1.8 Units on a scale
Standard Deviation 20.71
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 561 (n=17)
|
-2.0 Units on a scale
Standard Deviation 29.98
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 617 (n=14)
|
0.0 Units on a scale
Standard Deviation 29.24
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 673 (n=11)
|
-6.1 Units on a scale
Standard Deviation 29.13
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 897 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at Day 953 (n=1)
|
0.0 Units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Financial difficulties: Change at follow-up (n=12)
|
0.0 Units on a scale
Standard Deviation 14.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeksData for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Outcome measures
Outcome data not reported
Adverse Events
Axitinib
Serious events: 28 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Axitinib
n=52 participants at risk
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia Not otherwise specified (NOS)
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia NOS
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiomyopathy NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Pericarditis NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Weakness
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bone infection NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal infection NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infusion site infection
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Perianal abscess
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Skin infection NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Blister
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Spinal cord compression NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Polyuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Hernia repair NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension aggravated
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Axitinib
n=52 participants at risk
Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
13/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
38.5%
20/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
63.5%
33/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
21.2%
11/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
21.2%
11/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
59.6%
31/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
21.2%
11/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
28.8%
15/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
63.5%
33/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
11.5%
6/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
21.2%
11/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
8/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Weight decreased
|
36.5%
19/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.3%
22/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.5%
19/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.9%
14/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.4%
8/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.5%
6/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.4%
8/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.8%
16/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
30.8%
16/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Memory impairment
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sensory disturbance
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.8%
15/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
40.4%
21/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.9%
14/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.5%
6/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.3%
9/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
34.6%
18/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.5%
6/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
59.6%
31/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one 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