Trial Outcomes & Findings for A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors (NCT NCT01525550)
NCT ID: NCT01525550
Last Updated: 2019-07-30
Results Overview
Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (\>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
COMPLETED
PHASE4
106 participants
Baseline until disease progression or death due to any cause (up to 1226 days)
2019-07-30
Participant Flow
"End of treatment" for outcome measures of ECOG-PS, EORTC QLQ-C30 and EORTC QLQ-GI NET 21 was up to "primary completion date" (PCD) only.
Participant milestones
| Measure |
Sunitinib: Treatment Naive Cohort
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
45
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
45
|
Reasons for withdrawal
| Measure |
Sunitinib: Treatment Naive Cohort
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
|
Overall Study
Death
|
19
|
28
|
|
Overall Study
Other
|
0
|
4
|
|
Overall Study
Sponsor's Decision
|
30
|
11
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline until disease progression or death due to any cause (up to 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (\>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Progression-Free Survival (PFS): Investigator Assessment
|
13.2 months
Interval 7.4 to 16.8
|
13.0 months
Interval 9.2 to 20.4
|
SECONDARY outcome
Timeframe: Baseline until disease progression or death due to any cause (up to 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
IRR assessed PFS was defined as the time (in months) from the date of enrollment in study until the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per RECIST 1.0 criteria was defined as: \>=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment
|
11.1 months
Interval 5.5 to 16.7
|
9.5 months
Interval 7.4 to 18.4
|
SECONDARY outcome
Timeframe: Baseline until first documented tumor progression (up to 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
Investigator assessed TTP was defined as the time (in months) from the date of enrollment in study until the date of first documentation of objective tumor progression. TTP calculated as (first event date minus date of enrollment plus 1)/30.4. Progression as per RECIST 1.0 was defined as \>=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Time to Tumor Progression (TTP): Investigator Assessment
|
14.8 months
Interval 7.5 to 16.8
|
14.5 months
Interval 9.2 to 20.4
|
SECONDARY outcome
Timeframe: Baseline until death or end of study (up to 1939 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
OS was defined as the time (in months) from date of enrollment in study to the date of death due to any cause. If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive or the end of study. The analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 41.7 to
Median and upper limit of 95% CI was not estimable due to the low number of participants who died.
|
37.9 Months
Interval 22.9 to 56.1
|
SECONDARY outcome
Timeframe: Baseline until disease progression or death due to any cause (up to 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
Investigator assessed OR in participants was defined as having a complete response (CR) or partial response (PR) according to RECIST 1.0 and sustained for at least 4 weeks. CR was defined as disappearance of all target and non-target lesions. PR was defined as \>=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Percentage of participants with investigator assessed OR were reported.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Percentage of Participants With Objective Response (OR): Investigator Assessment
|
21.3 percentage of participants
Interval 11.9 to 33.7
|
28.9 percentage of participants
Interval 16.4 to 44.3
|
SECONDARY outcome
Timeframe: Baseline until disease progression or death due to any cause (up to 1226 days)Population: Analysis was performed on only those participants who had objective response as per investigator assessment.
Investigator assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR), that was subsequently confirmed, to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to RECIST 1.0, CR was defined as disappearance of all target and non-target lesions. PR was defined as \>=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Progression as per RECIST version 1.0 was defined as \>=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=13 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=13 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Duration of Response (DOR): Investigator Assessment
|
19.1 months
Interval 10.1 to
Upper limit of 95% CI was not estimable due to the low number of participants with events.
|
14.7 months
Interval 5.5 to 21.9
|
SECONDARY outcome
Timeframe: Baseline until first documented objective tumor response (up to 1226 days)Population: Analysis was performed on only those participants who had objective response as per investigator assessment.
Investigator assessed TTR was defined as the time (in months) from date of enrollment in study until date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. As per RECIST 1.0, CR was defined as disappearance of all target and non-target lesions and PR was defined as \>=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=13 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=13 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Time to Tumor Response (TTR): Investigator Assessment
|
3.8 months
Interval 1.0 to 11.1
|
3.8 months
Interval 1.0 to 9.3
|
SECONDARY outcome
Timeframe: Baseline until disease progression or death due to any cause (up to 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
IRR assessed OR in participants was defined as having a CR or PR according to Choi criteria and sustained for at least 4 weeks. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of \>=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on Computed tomography (CT) with no new lesions and no obvious progression of non-measurable disease. Percentage of participants with objective response were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment
|
52.5 percentage of participants
Interval 39.3 to 65.4
|
55.6 percentage of participants
Interval 40.0 to 70.4
|
SECONDARY outcome
Timeframe: Baseline until disease progression or death due to any cause (up to 1226 days)Population: Analysis was performed on only those participants who had objective response as per IRR assessment.
IRR assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR) that was subsequently confirmed to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of \>=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=32 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=25 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Duration of Response (DOR): Independent Radiological Review (IRR) Assessment
|
NA months
Interval 17.8 to
Median and 95% CI was not estimable due to the small number of participants who encountered tumor progression or death.
|
19.2 months
Interval 15.7 to 35.9
|
SECONDARY outcome
Timeframe: Baseline until first documented objective tumor response (up to 1226 days)Population: Analysis was performed on only those participants who had objective response as per IRR assessment.
IRR assessed TTR was defined as the time (in months) from date of enrollment in study until first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of \>=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=32 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=25 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment
|
1.0 months
Interval 0.8 to 7.3
|
1.0 months
Interval 0.9 to 3.7
|
SECONDARY outcome
Timeframe: Baseline until CgA response or death due to any cause (up to 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.
CgA response in participants was defined as having confirmed CgA CR or CgA PR, relative to the population with an elevated baseline CgA value in the blood. CgA CR was defined as decrease from a high baseline value of CgA in the blood to one that fell within the normal range. CgA PR was defined as a decrease of greater than or equal to 50 percent from a high baseline value of CgA. Normal baseline value of CgA in blood was 39.0 ng/mL. Confirmed responses were those that persisted for at least 4 weeks after initial documentation of response. Blood levels of CgA were assessed and percentage of participants with CgA response were reported.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Percentage of Participants With Chromogranin A (CgA) Response
|
16.4 percentage of participants
Interval 9.6 to 32.5
|
11.1 percentage of participants
Interval 4.0 to 25.6
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, "0 participants" in the "number analyzed" field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess the participant quality of life. First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Each question was assessed on 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); high score represented high level of symptomatology/problem. Last 2 questions used for evaluating global health status (GHS)/quality of life. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 34
|
64.44 units on a scale
Standard Deviation 21.430
|
80.00 units on a scale
Standard Deviation 12.649
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 35
|
70.00 units on a scale
Standard Deviation 23.570
|
78.89 units on a scale
Standard Deviation 12.939
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 36
|
86.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
80.00 units on a scale
Standard Deviation 9.428
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 37
|
86.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
76.67 units on a scale
Standard Deviation 3.849
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 38
|
—
|
75.00 units on a scale
Standard Deviation 6.383
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 39
|
86.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
77.78 units on a scale
Standard Deviation 3.849
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 40
|
93.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
71.11 units on a scale
Standard Deviation 10.184
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 41
|
—
|
77.78 units on a scale
Standard Deviation 10.184
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: EOT
|
76.16 units on a scale
Standard Deviation 23.454
|
78.00 units on a scale
Standard Deviation 19.191
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 1
|
88.33 units on a scale
Standard Deviation 20.424
|
85.61 units on a scale
Standard Deviation 18.880
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 2
|
85.67 units on a scale
Standard Deviation 17.089
|
80.56 units on a scale
Standard Deviation 25.214
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 3
|
85.15 units on a scale
Standard Deviation 18.613
|
80.83 units on a scale
Standard Deviation 25.473
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 4
|
84.67 units on a scale
Standard Deviation 17.444
|
80.26 units on a scale
Standard Deviation 23.841
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 5
|
85.82 units on a scale
Standard Deviation 19.343
|
82.35 units on a scale
Standard Deviation 23.904
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 6
|
86.05 units on a scale
Standard Deviation 16.639
|
79.57 units on a scale
Standard Deviation 25.353
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 7
|
83.33 units on a scale
Standard Deviation 21.965
|
81.03 units on a scale
Standard Deviation 24.285
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 8
|
80.63 units on a scale
Standard Deviation 19.049
|
85.33 units on a scale
Standard Deviation 16.887
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 9
|
76.19 units on a scale
Standard Deviation 22.968
|
80.77 units on a scale
Standard Deviation 22.945
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 10
|
82.86 units on a scale
Standard Deviation 18.737
|
83.33 units on a scale
Standard Deviation 23.028
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 11
|
79.52 units on a scale
Standard Deviation 22.537
|
86.11 units on a scale
Standard Deviation 18.822
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 12
|
79.52 units on a scale
Standard Deviation 20.246
|
84.85 units on a scale
Standard Deviation 19.182
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 13
|
82.35 units on a scale
Standard Deviation 19.219
|
84.13 units on a scale
Standard Deviation 17.059
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 14
|
81.72 units on a scale
Standard Deviation 20.346
|
79.82 units on a scale
Standard Deviation 19.704
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 15
|
77.22 units on a scale
Standard Deviation 22.946
|
77.45 units on a scale
Standard Deviation 22.777
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 22
|
68.18 units on a scale
Standard Deviation 29.302
|
71.21 units on a scale
Standard Deviation 29.899
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 23
|
63.64 units on a scale
Standard Deviation 30.567
|
71.67 units on a scale
Standard Deviation 24.907
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 24
|
60.00 units on a scale
Standard Deviation 27.442
|
76.67 units on a scale
Standard Deviation 22.498
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 25
|
58.33 units on a scale
Standard Deviation 30.682
|
77.08 units on a scale
Standard Deviation 23.465
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 26
|
57.14 units on a scale
Standard Deviation 30.211
|
83.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 27
|
58.33 units on a scale
Standard Deviation 36.132
|
77.08 units on a scale
Standard Deviation 23.465
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 29
|
75.00 units on a scale
Standard Deviation 13.944
|
78.57 units on a scale
Standard Deviation 24.934
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 30
|
90.00 units on a scale
Standard Deviation 14.907
|
76.19 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 31
|
83.33 units on a scale
Standard Deviation 16.667
|
78.57 units on a scale
Standard Deviation 24.934
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 35
|
75.00 units on a scale
Standard Deviation 35.355
|
72.22 units on a scale
Standard Deviation 25.092
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 7
|
80.56 units on a scale
Standard Deviation 21.059
|
73.56 units on a scale
Standard Deviation 26.075
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 16
|
82.10 units on a scale
Standard Deviation 22.133
|
75.00 units on a scale
Standard Deviation 24.343
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 18
|
78.92 units on a scale
Standard Deviation 23.592
|
76.19 units on a scale
Standard Deviation 25.499
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 19
|
73.61 units on a scale
Standard Deviation 28.611
|
73.81 units on a scale
Standard Deviation 25.288
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 22
|
75.76 units on a scale
Standard Deviation 30.834
|
78.03 units on a scale
Standard Deviation 22.445
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 37
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
77.08 units on a scale
Standard Deviation 35.600
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 39
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
63.89 units on a scale
Standard Deviation 48.829
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: EOT
|
67.17 units on a scale
Standard Deviation 23.748
|
66.94 units on a scale
Standard Deviation 27.024
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 3
|
89.09 units on a scale
Standard Deviation 15.119
|
87.50 units on a scale
Standard Deviation 19.882
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 8
|
87.39 units on a scale
Standard Deviation 13.836
|
83.33 units on a scale
Standard Deviation 21.517
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 11
|
86.67 units on a scale
Standard Deviation 16.068
|
86.11 units on a scale
Standard Deviation 17.492
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 16
|
88.27 units on a scale
Standard Deviation 12.067
|
80.21 units on a scale
Standard Deviation 24.509
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 17
|
89.39 units on a scale
Standard Deviation 12.112
|
84.44 units on a scale
Standard Deviation 20.380
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 19
|
88.89 units on a scale
Standard Deviation 12.975
|
78.57 units on a scale
Standard Deviation 24.832
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 22
|
86.36 units on a scale
Standard Deviation 12.513
|
81.82 units on a scale
Standard Deviation 20.350
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 24
|
85.00 units on a scale
Standard Deviation 16.574
|
81.67 units on a scale
Standard Deviation 19.954
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 25
|
81.67 units on a scale
Standard Deviation 18.342
|
75.00 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 27
|
75.00 units on a scale
Standard Deviation 20.412
|
77.08 units on a scale
Standard Deviation 25.099
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 31
|
83.33 units on a scale
Standard Deviation 23.570
|
73.81 units on a scale
Standard Deviation 31.706
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 1
|
80.87 units on a scale
Standard Deviation 23.734
|
79.46 units on a scale
Standard Deviation 25.675
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 2
|
83.04 units on a scale
Standard Deviation 20.288
|
82.93 units on a scale
Standard Deviation 20.578
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 4
|
81.67 units on a scale
Standard Deviation 21.626
|
79.82 units on a scale
Standard Deviation 25.160
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 5
|
80.85 units on a scale
Standard Deviation 21.697
|
79.41 units on a scale
Standard Deviation 26.291
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 7
|
80.34 units on a scale
Standard Deviation 22.579
|
83.91 units on a scale
Standard Deviation 27.271
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 8
|
78.83 units on a scale
Standard Deviation 21.748
|
80.00 units on a scale
Standard Deviation 25.909
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 12
|
75.71 units on a scale
Standard Deviation 25.030
|
81.82 units on a scale
Standard Deviation 27.172
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 29
|
80.00 units on a scale
Standard Deviation 18.257
|
71.43 units on a scale
Standard Deviation 34.311
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 30
|
75.00 units on a scale
Standard Deviation 31.914
|
69.05 units on a scale
Standard Deviation 36.551
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 31
|
66.67 units on a scale
Standard Deviation 47.140
|
71.43 units on a scale
Standard Deviation 35.635
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 35
|
66.67 units on a scale
Standard Deviation 23.570
|
72.22 units on a scale
Standard Deviation 37.515
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 42
|
—
|
41.67 units on a scale
Standard Deviation 35.355
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 1
|
21.49 units on a scale
Standard Deviation 20.374
|
29.42 units on a scale
Standard Deviation 17.835
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 2
|
24.37 units on a scale
Standard Deviation 17.995
|
29.10 units on a scale
Standard Deviation 19.001
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 5
|
26.00 units on a scale
Standard Deviation 17.069
|
27.61 units on a scale
Standard Deviation 23.865
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 9
|
26.35 units on a scale
Standard Deviation 20.182
|
22.22 units on a scale
Standard Deviation 20.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 10
|
26.03 units on a scale
Standard Deviation 19.975
|
24.64 units on a scale
Standard Deviation 23.914
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 14
|
24.73 units on a scale
Standard Deviation 19.183
|
24.56 units on a scale
Standard Deviation 20.813
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 15
|
24.07 units on a scale
Standard Deviation 20.443
|
24.84 units on a scale
Standard Deviation 24.066
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 20
|
34.34 units on a scale
Standard Deviation 26.036
|
22.22 units on a scale
Standard Deviation 18.144
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 26
|
44.44 units on a scale
Standard Deviation 27.962
|
22.22 units on a scale
Standard Deviation 14.344
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 27
|
50.00 units on a scale
Standard Deviation 30.429
|
26.39 units on a scale
Standard Deviation 22.954
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 28
|
42.86 units on a scale
Standard Deviation 28.276
|
30.56 units on a scale
Standard Deviation 26.394
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 30
|
24.44 units on a scale
Standard Deviation 18.257
|
31.75 units on a scale
Standard Deviation 27.539
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 31
|
22.22 units on a scale
Standard Deviation 29.397
|
31.75 units on a scale
Standard Deviation 29.696
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 34
|
37.04 units on a scale
Standard Deviation 35.717
|
40.74 units on a scale
Standard Deviation 16.728
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 35
|
33.33 units on a scale
Standard Deviation 47.140
|
35.19 units on a scale
Standard Deviation 16.355
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
51.85 units on a scale
Standard Deviation 33.945
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 1
|
6.56 units on a scale
Standard Deviation 13.010
|
7.95 units on a scale
Standard Deviation 17.420
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 4
|
8.00 units on a scale
Standard Deviation 13.569
|
4.39 units on a scale
Standard Deviation 9.238
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 8
|
7.66 units on a scale
Standard Deviation 15.513
|
3.33 units on a scale
Standard Deviation 6.804
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 10
|
5.71 units on a scale
Standard Deviation 12.088
|
4.35 units on a scale
Standard Deviation 9.014
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 16
|
4.32 units on a scale
Standard Deviation 9.906
|
3.13 units on a scale
Standard Deviation 9.065
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 28
|
9.52 units on a scale
Standard Deviation 18.898
|
2.08 units on a scale
Standard Deviation 5.893
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 32
|
5.56 units on a scale
Standard Deviation 9.623
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 41
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 1
|
16.39 units on a scale
Standard Deviation 20.067
|
18.18 units on a scale
Standard Deviation 18.958
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 2
|
16.67 units on a scale
Standard Deviation 18.094
|
19.05 units on a scale
Standard Deviation 20.353
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 4
|
14.00 units on a scale
Standard Deviation 15.922
|
23.25 units on a scale
Standard Deviation 24.056
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 5
|
15.96 units on a scale
Standard Deviation 16.651
|
18.14 units on a scale
Standard Deviation 22.235
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 6
|
15.89 units on a scale
Standard Deviation 17.041
|
20.43 units on a scale
Standard Deviation 26.073
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 7
|
20.09 units on a scale
Standard Deviation 21.690
|
22.99 units on a scale
Standard Deviation 22.893
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 8
|
17.57 units on a scale
Standard Deviation 17.099
|
14.67 units on a scale
Standard Deviation 16.887
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 12
|
20.48 units on a scale
Standard Deviation 22.172
|
16.67 units on a scale
Standard Deviation 17.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 14
|
14.52 units on a scale
Standard Deviation 17.074
|
21.05 units on a scale
Standard Deviation 19.909
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 20
|
25.76 units on a scale
Standard Deviation 27.247
|
12.82 units on a scale
Standard Deviation 15.447
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 21
|
25.76 units on a scale
Standard Deviation 29.215
|
16.67 units on a scale
Standard Deviation 21.320
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 23
|
21.21 units on a scale
Standard Deviation 27.979
|
15.00 units on a scale
Standard Deviation 22.839
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 27
|
47.22 units on a scale
Standard Deviation 35.616
|
20.83 units on a scale
Standard Deviation 21.362
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 28
|
35.71 units on a scale
Standard Deviation 33.923
|
22.92 units on a scale
Standard Deviation 25.099
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 30
|
20.00 units on a scale
Standard Deviation 21.731
|
19.05 units on a scale
Standard Deviation 24.398
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 31
|
16.67 units on a scale
Standard Deviation 28.868
|
26.19 units on a scale
Standard Deviation 23.288
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 32
|
16.67 units on a scale
Standard Deviation 28.868
|
27.78 units on a scale
Standard Deviation 31.032
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 33
|
16.67 units on a scale
Standard Deviation 28.868
|
25.00 units on a scale
Standard Deviation 25.276
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 37
|
16.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
29.17 units on a scale
Standard Deviation 28.464
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 4
|
6.00 units on a scale
Standard Deviation 12.936
|
13.16 units on a scale
Standard Deviation 21.280
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 7
|
11.11 units on a scale
Standard Deviation 22.076
|
10.34 units on a scale
Standard Deviation 20.125
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 20
|
6.06 units on a scale
Standard Deviation 13.484
|
5.13 units on a scale
Standard Deviation 12.518
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 21
|
12.12 units on a scale
Standard Deviation 16.817
|
8.33 units on a scale
Standard Deviation 15.076
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 30
|
6.67 units on a scale
Standard Deviation 14.907
|
14.29 units on a scale
Standard Deviation 17.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 34
|
11.11 units on a scale
Standard Deviation 19.245
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 38
|
—
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: EOT
|
14.14 units on a scale
Standard Deviation 16.730
|
13.33 units on a scale
Standard Deviation 24.132
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 2
|
9.36 units on a scale
Standard Deviation 16.372
|
19.84 units on a scale
Standard Deviation 23.350
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 3
|
12.12 units on a scale
Standard Deviation 17.408
|
26.67 units on a scale
Standard Deviation 26.366
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 10
|
12.38 units on a scale
Standard Deviation 18.232
|
21.74 units on a scale
Standard Deviation 21.576
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 11
|
12.38 units on a scale
Standard Deviation 18.232
|
22.22 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 12
|
6.67 units on a scale
Standard Deviation 15.760
|
22.73 units on a scale
Standard Deviation 27.958
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 14
|
8.60 units on a scale
Standard Deviation 17.144
|
22.81 units on a scale
Standard Deviation 19.413
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 18
|
11.76 units on a scale
Standard Deviation 16.420
|
23.81 units on a scale
Standard Deviation 24.209
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 19
|
13.89 units on a scale
Standard Deviation 22.285
|
23.81 units on a scale
Standard Deviation 24.209
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 20
|
9.09 units on a scale
Standard Deviation 15.570
|
25.64 units on a scale
Standard Deviation 24.167
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 22
|
15.15 units on a scale
Standard Deviation 22.918
|
30.30 units on a scale
Standard Deviation 27.707
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 23
|
15.15 units on a scale
Standard Deviation 17.408
|
30.00 units on a scale
Standard Deviation 33.148
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 24
|
10.00 units on a scale
Standard Deviation 22.498
|
33.33 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 26
|
9.52 units on a scale
Standard Deviation 16.265
|
23.81 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 27
|
27.78 units on a scale
Standard Deviation 38.968
|
33.33 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 28
|
23.81 units on a scale
Standard Deviation 25.198
|
25.00 units on a scale
Standard Deviation 29.547
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 29
|
22.22 units on a scale
Standard Deviation 27.217
|
38.10 units on a scale
Standard Deviation 35.635
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 30
|
6.67 units on a scale
Standard Deviation 14.907
|
28.57 units on a scale
Standard Deviation 29.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 31
|
11.11 units on a scale
Standard Deviation 19.245
|
19.05 units on a scale
Standard Deviation 26.227
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 32
|
22.22 units on a scale
Standard Deviation 19.245
|
27.78 units on a scale
Standard Deviation 25.092
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 35
|
16.67 units on a scale
Standard Deviation 23.570
|
27.78 units on a scale
Standard Deviation 25.092
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
26.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 38
|
—
|
33.33 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
22.22 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 42
|
—
|
16.67 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 43
|
—
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: EOT
|
16.16 units on a scale
Standard Deviation 26.512
|
25.56 units on a scale
Standard Deviation 33.543
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 2
|
16.96 units on a scale
Standard Deviation 21.009
|
18.25 units on a scale
Standard Deviation 22.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 4
|
14.00 units on a scale
Standard Deviation 24.365
|
16.67 units on a scale
Standard Deviation 26.565
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 5
|
10.64 units on a scale
Standard Deviation 20.974
|
15.69 units on a scale
Standard Deviation 28.704
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 6
|
10.85 units on a scale
Standard Deviation 20.212
|
18.28 units on a scale
Standard Deviation 30.839
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 7
|
14.53 units on a scale
Standard Deviation 22.679
|
14.94 units on a scale
Standard Deviation 28.986
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 8
|
16.22 units on a scale
Standard Deviation 25.606
|
14.67 units on a scale
Standard Deviation 25.604
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 9
|
14.29 units on a scale
Standard Deviation 18.587
|
14.10 units on a scale
Standard Deviation 26.954
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 10
|
13.33 units on a scale
Standard Deviation 21.693
|
17.39 units on a scale
Standard Deviation 28.194
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 11
|
15.24 units on a scale
Standard Deviation 21.907
|
8.33 units on a scale
Standard Deviation 22.522
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 12
|
13.33 units on a scale
Standard Deviation 25.820
|
12.12 units on a scale
Standard Deviation 24.224
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 13
|
13.73 units on a scale
Standard Deviation 21.893
|
7.94 units on a scale
Standard Deviation 14.548
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 14
|
10.75 units on a scale
Standard Deviation 21.751
|
10.53 units on a scale
Standard Deviation 19.413
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 15
|
13.33 units on a scale
Standard Deviation 24.132
|
15.69 units on a scale
Standard Deviation 29.149
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 16
|
13.58 units on a scale
Standard Deviation 23.130
|
8.33 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 19
|
19.44 units on a scale
Standard Deviation 33.207
|
9.52 units on a scale
Standard Deviation 27.514
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 20
|
21.21 units on a scale
Standard Deviation 34.230
|
5.13 units on a scale
Standard Deviation 12.518
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 21
|
21.21 units on a scale
Standard Deviation 34.230
|
16.67 units on a scale
Standard Deviation 22.473
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 22
|
18.18 units on a scale
Standard Deviation 31.140
|
15.15 units on a scale
Standard Deviation 22.918
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 23
|
18.18 units on a scale
Standard Deviation 31.140
|
10.00 units on a scale
Standard Deviation 22.498
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 24
|
23.33 units on a scale
Standard Deviation 35.312
|
13.33 units on a scale
Standard Deviation 23.307
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 25
|
23.33 units on a scale
Standard Deviation 41.722
|
8.33 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 26
|
38.10 units on a scale
Standard Deviation 48.795
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 27
|
33.33 units on a scale
Standard Deviation 42.164
|
12.50 units on a scale
Standard Deviation 35.355
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 28
|
28.57 units on a scale
Standard Deviation 40.500
|
16.67 units on a scale
Standard Deviation 35.635
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 30
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 32
|
11.11 units on a scale
Standard Deviation 19.245
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 33
|
22.22 units on a scale
Standard Deviation 38.490
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 35
|
33.33 units on a scale
Standard Deviation 47.140
|
11.11 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 2
|
3.51 units on a scale
Standard Deviation 10.321
|
13.49 units on a scale
Standard Deviation 26.605
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 3
|
7.27 units on a scale
Standard Deviation 15.303
|
4.17 units on a scale
Standard Deviation 13.477
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 4
|
6.67 units on a scale
Standard Deviation 15.058
|
5.26 units on a scale
Standard Deviation 12.318
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 5
|
3.55 units on a scale
Standard Deviation 12.499
|
2.94 units on a scale
Standard Deviation 12.627
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 6
|
3.88 units on a scale
Standard Deviation 10.812
|
2.15 units on a scale
Standard Deviation 8.324
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 7
|
3.42 units on a scale
Standard Deviation 10.245
|
5.75 units on a scale
Standard Deviation 17.970
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 8
|
3.60 units on a scale
Standard Deviation 13.109
|
4.00 units on a scale
Standard Deviation 14.657
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 9
|
6.67 units on a scale
Standard Deviation 15.760
|
3.85 units on a scale
Standard Deviation 14.382
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 10
|
2.86 units on a scale
Standard Deviation 9.468
|
5.80 units on a scale
Standard Deviation 16.368
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 12
|
5.71 units on a scale
Standard Deviation 12.746
|
4.55 units on a scale
Standard Deviation 11.708
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 17
|
6.06 units on a scale
Standard Deviation 13.159
|
2.22 units on a scale
Standard Deviation 8.607
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 18
|
3.92 units on a scale
Standard Deviation 11.070
|
4.76 units on a scale
Standard Deviation 12.105
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 20
|
0.00 units on a scale
Standard Deviation 0.000
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 22
|
0.00 units on a scale
Standard Deviation 0.000
|
12.12 units on a scale
Standard Deviation 30.814
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 25
|
3.33 units on a scale
Standard Deviation 10.541
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 26
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 27
|
5.56 units on a scale
Standard Deviation 13.608
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 28
|
4.76 units on a scale
Standard Deviation 12.599
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 29
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 33
|
0.00 units on a scale
Standard Deviation 0.000
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 34
|
0.00 units on a scale
Standard Deviation 0.000
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
13.33 units on a scale
Standard Deviation 29.814
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 41
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 2
|
18.13 units on a scale
Standard Deviation 26.027
|
17.07 units on a scale
Standard Deviation 25.951
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 3
|
16.36 units on a scale
Standard Deviation 24.740
|
24.17 units on a scale
Standard Deviation 25.021
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 4
|
22.00 units on a scale
Standard Deviation 27.446
|
15.79 units on a scale
Standard Deviation 21.556
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 5
|
22.70 units on a scale
Standard Deviation 26.105
|
21.57 units on a scale
Standard Deviation 23.039
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 6
|
24.03 units on a scale
Standard Deviation 29.390
|
22.58 units on a scale
Standard Deviation 21.751
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 7
|
29.06 units on a scale
Standard Deviation 27.762
|
25.29 units on a scale
Standard Deviation 29.080
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 11
|
23.81 units on a scale
Standard Deviation 25.012
|
23.61 units on a scale
Standard Deviation 23.008
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 12
|
21.90 units on a scale
Standard Deviation 22.785
|
18.18 units on a scale
Standard Deviation 22.366
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 16
|
18.52 units on a scale
Standard Deviation 25.036
|
20.83 units on a scale
Standard Deviation 20.638
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 18
|
25.49 units on a scale
Standard Deviation 27.712
|
19.05 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 19
|
13.89 units on a scale
Standard Deviation 17.164
|
19.05 units on a scale
Standard Deviation 21.540
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 21
|
33.33 units on a scale
Standard Deviation 29.814
|
25.00 units on a scale
Standard Deviation 28.868
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 22
|
18.18 units on a scale
Standard Deviation 31.140
|
21.21 units on a scale
Standard Deviation 26.968
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 23
|
24.24 units on a scale
Standard Deviation 33.635
|
26.67 units on a scale
Standard Deviation 30.631
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 25
|
16.67 units on a scale
Standard Deviation 17.568
|
29.17 units on a scale
Standard Deviation 27.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 26
|
19.05 units on a scale
Standard Deviation 26.227
|
28.57 units on a scale
Standard Deviation 29.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 29
|
0.00 units on a scale
Standard Deviation 0.000
|
28.57 units on a scale
Standard Deviation 29.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 30
|
0.00 units on a scale
Standard Deviation 0.000
|
38.10 units on a scale
Standard Deviation 23.002
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 32
|
22.22 units on a scale
Standard Deviation 19.245
|
50.00 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 33
|
11.11 units on a scale
Standard Deviation 19.245
|
50.00 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 34
|
33.33 units on a scale
Standard Deviation 33.333
|
44.44 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 35
|
16.67 units on a scale
Standard Deviation 23.570
|
38.89 units on a scale
Standard Deviation 32.773
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
40.00 units on a scale
Standard Deviation 43.461
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
33.33 units on a scale
Standard Deviation 33.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
44.44 units on a scale
Standard Deviation 38.490
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: EOT
|
24.24 units on a scale
Standard Deviation 29.194
|
17.78 units on a scale
Standard Deviation 24.343
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 3
|
23.03 units on a scale
Standard Deviation 30.002
|
30.00 units on a scale
Standard Deviation 34.427
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 5
|
26.24 units on a scale
Standard Deviation 34.005
|
25.49 units on a scale
Standard Deviation 29.654
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 7
|
29.06 units on a scale
Standard Deviation 31.696
|
27.59 units on a scale
Standard Deviation 32.206
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 10
|
25.71 units on a scale
Standard Deviation 28.105
|
24.64 units on a scale
Standard Deviation 30.513
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 11
|
26.67 units on a scale
Standard Deviation 27.771
|
23.61 units on a scale
Standard Deviation 28.622
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 13
|
23.53 units on a scale
Standard Deviation 27.864
|
19.05 units on a scale
Standard Deviation 30.861
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 14
|
23.66 units on a scale
Standard Deviation 28.795
|
17.54 units on a scale
Standard Deviation 28.040
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 15
|
21.11 units on a scale
Standard Deviation 22.289
|
19.61 units on a scale
Standard Deviation 29.009
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 16
|
22.22 units on a scale
Standard Deviation 22.646
|
18.75 units on a scale
Standard Deviation 29.736
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 18
|
17.65 units on a scale
Standard Deviation 29.149
|
16.67 units on a scale
Standard Deviation 21.681
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 19
|
22.22 units on a scale
Standard Deviation 32.824
|
14.29 units on a scale
Standard Deviation 17.118
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 20
|
15.15 units on a scale
Standard Deviation 22.918
|
15.38 units on a scale
Standard Deviation 29.235
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 21
|
24.24 units on a scale
Standard Deviation 33.635
|
16.67 units on a scale
Standard Deviation 30.151
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 23
|
15.15 units on a scale
Standard Deviation 22.918
|
20.00 units on a scale
Standard Deviation 32.203
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 26
|
23.81 units on a scale
Standard Deviation 31.706
|
28.57 units on a scale
Standard Deviation 40.500
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 27
|
16.67 units on a scale
Standard Deviation 27.889
|
20.83 units on a scale
Standard Deviation 35.355
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 28
|
19.05 units on a scale
Standard Deviation 26.227
|
20.83 units on a scale
Standard Deviation 35.355
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 29
|
13.33 units on a scale
Standard Deviation 29.814
|
19.05 units on a scale
Standard Deviation 37.796
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 30
|
16.67 units on a scale
Standard Deviation 33.333
|
19.05 units on a scale
Standard Deviation 37.796
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 31
|
33.33 units on a scale
Standard Deviation 47.140
|
19.05 units on a scale
Standard Deviation 37.796
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 33
|
33.33 units on a scale
Standard Deviation 33.333
|
22.22 units on a scale
Standard Deviation 40.369
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 34
|
22.22 units on a scale
Standard Deviation 19.245
|
22.22 units on a scale
Standard Deviation 40.369
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 35
|
50.00 units on a scale
Standard Deviation 23.570
|
22.22 units on a scale
Standard Deviation 40.369
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
20.00 units on a scale
Standard Deviation 44.721
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 41
|
—
|
22.22 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: EOT
|
30.30 units on a scale
Standard Deviation 29.302
|
23.33 units on a scale
Standard Deviation 26.479
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 22
|
56.06 units on a scale
Standard Deviation 23.889
|
62.88 units on a scale
Standard Deviation 27.224
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 30
|
52.08 units on a scale
Standard Deviation 21.916
|
64.29 units on a scale
Standard Deviation 14.996
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 7
|
86.24 units on a scale
Standard Deviation 12.891
|
84.14 units on a scale
Standard Deviation 15.473
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 11
|
84.19 units on a scale
Standard Deviation 12.944
|
90.83 units on a scale
Standard Deviation 10.552
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 12
|
84.38 units on a scale
Standard Deviation 15.419
|
88.48 units on a scale
Standard Deviation 11.489
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 13
|
87.45 units on a scale
Standard Deviation 11.808
|
89.52 units on a scale
Standard Deviation 10.016
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 23
|
77.73 units on a scale
Standard Deviation 18.170
|
82.67 units on a scale
Standard Deviation 14.470
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status:Cycle 1
|
71.31 units on a scale
Standard Deviation 21.111
|
66.09 units on a scale
Standard Deviation 20.282
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 2
|
69.94 units on a scale
Standard Deviation 19.311
|
65.45 units on a scale
Standard Deviation 20.880
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 3
|
70.30 units on a scale
Standard Deviation 21.502
|
60.83 units on a scale
Standard Deviation 26.768
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 4
|
70.00 units on a scale
Standard Deviation 21.429
|
61.84 units on a scale
Standard Deviation 25.010
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 5
|
69.15 units on a scale
Standard Deviation 19.421
|
65.93 units on a scale
Standard Deviation 24.306
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 6
|
68.41 units on a scale
Standard Deviation 18.053
|
65.32 units on a scale
Standard Deviation 20.310
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 7
|
68.38 units on a scale
Standard Deviation 21.132
|
61.21 units on a scale
Standard Deviation 24.016
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 8
|
70.05 units on a scale
Standard Deviation 17.062
|
65.33 units on a scale
Standard Deviation 20.649
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 9
|
66.90 units on a scale
Standard Deviation 20.058
|
65.71 units on a scale
Standard Deviation 20.045
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 10
|
68.10 units on a scale
Standard Deviation 20.561
|
63.04 units on a scale
Standard Deviation 18.434
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 11
|
63.81 units on a scale
Standard Deviation 21.384
|
66.67 units on a scale
Standard Deviation 19.812
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 12
|
65.71 units on a scale
Standard Deviation 22.395
|
64.77 units on a scale
Standard Deviation 22.848
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 13
|
67.89 units on a scale
Standard Deviation 20.733
|
66.67 units on a scale
Standard Deviation 19.365
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 14
|
68.28 units on a scale
Standard Deviation 20.797
|
57.89 units on a scale
Standard Deviation 18.937
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 15
|
66.67 units on a scale
Standard Deviation 22.318
|
64.71 units on a scale
Standard Deviation 21.757
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 16
|
64.51 units on a scale
Standard Deviation 21.005
|
67.19 units on a scale
Standard Deviation 17.339
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 17
|
62.50 units on a scale
Standard Deviation 23.110
|
67.78 units on a scale
Standard Deviation 15.706
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 18
|
58.33 units on a scale
Standard Deviation 24.826
|
70.83 units on a scale
Standard Deviation 18.125
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 19
|
54.86 units on a scale
Standard Deviation 24.736
|
66.67 units on a scale
Standard Deviation 20.672
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 20
|
55.30 units on a scale
Standard Deviation 25.893
|
64.74 units on a scale
Standard Deviation 17.398
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 21
|
55.30 units on a scale
Standard Deviation 23.650
|
65.28 units on a scale
Standard Deviation 18.407
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 23
|
56.82 units on a scale
Standard Deviation 24.386
|
59.17 units on a scale
Standard Deviation 20.953
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 24
|
50.00 units on a scale
Standard Deviation 23.570
|
60.83 units on a scale
Standard Deviation 19.265
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 25
|
51.67 units on a scale
Standard Deviation 19.954
|
61.46 units on a scale
Standard Deviation 16.022
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 26
|
50.00 units on a scale
Standard Deviation 20.972
|
65.48 units on a scale
Standard Deviation 13.968
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 27
|
41.67 units on a scale
Standard Deviation 12.910
|
61.46 units on a scale
Standard Deviation 17.216
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 28
|
44.05 units on a scale
Standard Deviation 20.813
|
61.46 units on a scale
Standard Deviation 16.022
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 29
|
56.67 units on a scale
Standard Deviation 19.003
|
63.10 units on a scale
Standard Deviation 16.567
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 31
|
58.33 units on a scale
Standard Deviation 11.785
|
60.71 units on a scale
Standard Deviation 20.813
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 32
|
61.11 units on a scale
Standard Deviation 19.245
|
59.72 units on a scale
Standard Deviation 15.290
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 33
|
61.11 units on a scale
Standard Deviation 12.729
|
55.56 units on a scale
Standard Deviation 22.771
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 34
|
58.33 units on a scale
Standard Deviation 25.000
|
55.56 units on a scale
Standard Deviation 20.861
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 35
|
66.67 units on a scale
Standard Deviation 23.570
|
61.11 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 36
|
83.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
58.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 37
|
83.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
58.33 units on a scale
Standard Deviation 21.517
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 38
|
—
|
58.33 units on a scale
Standard Deviation 21.517
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 39
|
83.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
50.00 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 40
|
83.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
50.00 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 41
|
—
|
50.00 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 42
|
—
|
45.83 units on a scale
Standard Deviation 5.893
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: Cycle 43
|
—
|
50.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Global health status: EOT
|
60.10 units on a scale
Standard Deviation 22.318
|
50.00 units on a scale
Standard Deviation 22.210
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 1
|
90.38 units on a scale
Standard Deviation 14.733
|
86.93 units on a scale
Standard Deviation 12.677
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 2
|
89.71 units on a scale
Standard Deviation 10.988
|
86.51 units on a scale
Standard Deviation 13.929
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 3
|
88.73 units on a scale
Standard Deviation 12.886
|
85.00 units on a scale
Standard Deviation 17.263
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 4
|
89.07 units on a scale
Standard Deviation 10.412
|
83.68 units on a scale
Standard Deviation 16.958
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 5
|
88.23 units on a scale
Standard Deviation 11.311
|
87.06 units on a scale
Standard Deviation 17.519
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 6
|
87.91 units on a scale
Standard Deviation 11.293
|
83.44 units on a scale
Standard Deviation 18.924
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 8
|
85.23 units on a scale
Standard Deviation 12.486
|
88.27 units on a scale
Standard Deviation 11.102
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 9
|
84.00 units on a scale
Standard Deviation 13.255
|
87.18 units on a scale
Standard Deviation 14.474
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 10
|
86.67 units on a scale
Standard Deviation 11.771
|
87.25 units on a scale
Standard Deviation 15.943
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 14
|
86.67 units on a scale
Standard Deviation 12.996
|
86.67 units on a scale
Standard Deviation 10.423
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 15
|
85.33 units on a scale
Standard Deviation 11.534
|
89.02 units on a scale
Standard Deviation 11.041
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 16
|
83.70 units on a scale
Standard Deviation 18.053
|
89.58 units on a scale
Standard Deviation 10.319
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 17
|
82.42 units on a scale
Standard Deviation 16.657
|
88.00 units on a scale
Standard Deviation 9.155
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 18
|
82.35 units on a scale
Standard Deviation 18.248
|
90.95 units on a scale
Standard Deviation 8.516
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 19
|
75.00 units on a scale
Standard Deviation 22.406
|
89.52 units on a scale
Standard Deviation 9.324
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 20
|
74.55 units on a scale
Standard Deviation 20.181
|
89.74 units on a scale
Standard Deviation 8.439
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 21
|
75.15 units on a scale
Standard Deviation 17.911
|
90.00 units on a scale
Standard Deviation 7.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 22
|
77.58 units on a scale
Standard Deviation 22.563
|
81.82 units on a scale
Standard Deviation 24.782
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 24
|
72.67 units on a scale
Standard Deviation 22.760
|
82.67 units on a scale
Standard Deviation 14.807
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 25
|
74.67 units on a scale
Standard Deviation 23.685
|
89.17 units on a scale
Standard Deviation 10.653
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 26
|
66.67 units on a scale
Standard Deviation 25.531
|
83.81 units on a scale
Standard Deviation 13.801
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 27)
|
62.22 units on a scale
Standard Deviation 27.217
|
85.83 units on a scale
Standard Deviation 12.051
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 28
|
69.52 units on a scale
Standard Deviation 21.381
|
87.50 units on a scale
Standard Deviation 11.513
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 29
|
80.00 units on a scale
Standard Deviation 10.328
|
83.81 units on a scale
Standard Deviation 15.803
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 30
|
84.00 units on a scale
Standard Deviation 3.651
|
84.76 units on a scale
Standard Deviation 11.362
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 31
|
77.78 units on a scale
Standard Deviation 10.184
|
85.71 units on a scale
Standard Deviation 13.569
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 32
|
84.44 units on a scale
Standard Deviation 3.849
|
82.22 units on a scale
Standard Deviation 10.037
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 33
|
73.33 units on a scale
Standard Deviation 6.667
|
83.33 units on a scale
Standard Deviation 10.954
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 42
|
—
|
80.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Physical Functioning: Cycle 43
|
—
|
80.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 17
|
74.24 units on a scale
Standard Deviation 24.520
|
82.22 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 16
|
77.16 units on a scale
Standard Deviation 24.956
|
84.38 units on a scale
Standard Deviation 15.478
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 18
|
75.49 units on a scale
Standard Deviation 28.332
|
84.52 units on a scale
Standard Deviation 16.621
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 19
|
66.67 units on a scale
Standard Deviation 26.591
|
79.76 units on a scale
Standard Deviation 20.856
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 20
|
69.70 units on a scale
Standard Deviation 27.707
|
80.77 units on a scale
Standard Deviation 19.059
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 21
|
68.18 units on a scale
Standard Deviation 27.340
|
79.17 units on a scale
Standard Deviation 23.704
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 15
|
76.67 units on a scale
Standard Deviation 19.865
|
74.51 units on a scale
Standard Deviation 31.797
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 16
|
75.93 units on a scale
Standard Deviation 24.167
|
77.08 units on a scale
Standard Deviation 25.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 17
|
75.00 units on a scale
Standard Deviation 25.066
|
75.56 units on a scale
Standard Deviation 25.871
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 18
|
76.47 units on a scale
Standard Deviation 27.041
|
82.14 units on a scale
Standard Deviation 28.090
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 19
|
72.22 units on a scale
Standard Deviation 24.958
|
77.38 units on a scale
Standard Deviation 26.640
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 20
|
75.76 units on a scale
Standard Deviation 30.151
|
83.33 units on a scale
Standard Deviation 21.517
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 21
|
71.21 units on a scale
Standard Deviation 28.955
|
81.94 units on a scale
Standard Deviation 26.071
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 22
|
69.70 units on a scale
Standard Deviation 33.181
|
75.76 units on a scale
Standard Deviation 30.151
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 23
|
71.21 units on a scale
Standard Deviation 30.814
|
78.33 units on a scale
Standard Deviation 31.476
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 24
|
63.33 units on a scale
Standard Deviation 32.203
|
76.67 units on a scale
Standard Deviation 30.631
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 25
|
70.00 units on a scale
Standard Deviation 39.126
|
66.67 units on a scale
Standard Deviation 34.503
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 26
|
61.90 units on a scale
Standard Deviation 34.311
|
88.10 units on a scale
Standard Deviation 15.853
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 27
|
58.33 units on a scale
Standard Deviation 32.914
|
70.83 units on a scale
Standard Deviation 33.034
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 28
|
73.81 units on a scale
Standard Deviation 38.318
|
77.08 units on a scale
Standard Deviation 28.084
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 32
|
77.78 units on a scale
Standard Deviation 19.245
|
66.67 units on a scale
Standard Deviation 36.515
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 33
|
66.67 units on a scale
Standard Deviation 0.000
|
69.44 units on a scale
Standard Deviation 30.581
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 34
|
66.67 units on a scale
Standard Deviation 0.000
|
63.89 units on a scale
Standard Deviation 37.143
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 36
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
53.33 units on a scale
Standard Deviation 36.132
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 37
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
58.33 units on a scale
Standard Deviation 41.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 38
|
—
|
66.67 units on a scale
Standard Deviation 36.004
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 39
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
44.44 units on a scale
Standard Deviation 38.490
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 40
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
61.11 units on a scale
Standard Deviation 38.490
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 41
|
—
|
44.44 units on a scale
Standard Deviation 25.459
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 43
|
—
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: EOT
|
73.74 units on a scale
Standard Deviation 25.355
|
65.00 units on a scale
Standard Deviation 29.148
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 3
|
26.46 units on a scale
Standard Deviation 19.303
|
30.28 units on a scale
Standard Deviation 22.644
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 4
|
24.00 units on a scale
Standard Deviation 18.424
|
29.53 units on a scale
Standard Deviation 24.133
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 6
|
25.32 units on a scale
Standard Deviation 17.029
|
29.93 units on a scale
Standard Deviation 25.526
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 7
|
26.78 units on a scale
Standard Deviation 21.284
|
28.35 units on a scale
Standard Deviation 24.232
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 8
|
27.63 units on a scale
Standard Deviation 17.297
|
23.11 units on a scale
Standard Deviation 18.681
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 11
|
27.94 units on a scale
Standard Deviation 18.548
|
22.45 units on a scale
Standard Deviation 20.624
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 12
|
26.35 units on a scale
Standard Deviation 20.001
|
22.22 units on a scale
Standard Deviation 23.256
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 13
|
25.16 units on a scale
Standard Deviation 19.012
|
18.52 units on a scale
Standard Deviation 15.045
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 16
|
27.16 units on a scale
Standard Deviation 23.937
|
22.92 units on a scale
Standard Deviation 17.902
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 17
|
28.28 units on a scale
Standard Deviation 22.150
|
18.52 units on a scale
Standard Deviation 18.144
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 18
|
26.80 units on a scale
Standard Deviation 22.243
|
22.22 units on a scale
Standard Deviation 17.433
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 19
|
34.26 units on a scale
Standard Deviation 31.944
|
23.02 units on a scale
Standard Deviation 20.191
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 21
|
34.34 units on a scale
Standard Deviation 32.377
|
28.70 units on a scale
Standard Deviation 21.429
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 22
|
31.31 units on a scale
Standard Deviation 28.029
|
30.30 units on a scale
Standard Deviation 27.707
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 23
|
39.39 units on a scale
Standard Deviation 28.702
|
28.89 units on a scale
Standard Deviation 25.229
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 24
|
36.67 units on a scale
Standard Deviation 32.309
|
28.89 units on a scale
Standard Deviation 26.294
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 25
|
40.00 units on a scale
Standard Deviation 30.180
|
27.78 units on a scale
Standard Deviation 21.414
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 29
|
35.19 units on a scale
Standard Deviation 23.744
|
28.57 units on a scale
Standard Deviation 21.138
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 32
|
18.52 units on a scale
Standard Deviation 23.130
|
35.19 units on a scale
Standard Deviation 12.989
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 33
|
22.22 units on a scale
Standard Deviation 29.397
|
40.74 units on a scale
Standard Deviation 20.688
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
40.00 units on a scale
Standard Deviation 14.907
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
36.11 units on a scale
Standard Deviation 21.033
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 38
|
—
|
44.44 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 28
|
59.52 units on a scale
Standard Deviation 18.898
|
79.17 units on a scale
Standard Deviation 24.801
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
59.26 units on a scale
Standard Deviation 33.945
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 41
|
—
|
48.15 units on a scale
Standard Deviation 23.130
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 42
|
—
|
44.44 units on a scale
Standard Deviation 31.427
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: Cycle 43
|
—
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Fatigue: EOT
|
33.00 units on a scale
Standard Deviation 23.812
|
40.56 units on a scale
Standard Deviation 28.632
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 2
|
7.31 units on a scale
Standard Deviation 12.206
|
7.14 units on a scale
Standard Deviation 9.123
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 3
|
7.27 units on a scale
Standard Deviation 12.735
|
12.08 units on a scale
Standard Deviation 19.967
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 5
|
6.38 units on a scale
Standard Deviation 12.794
|
8.33 units on a scale
Standard Deviation 14.935
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 9
|
9.05 units on a scale
Standard Deviation 14.766
|
4.49 units on a scale
Standard Deviation 10.064
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 6
|
6.98 units on a scale
Standard Deviation 12.189
|
6.99 units on a scale
Standard Deviation 11.200
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 7
|
6.41 units on a scale
Standard Deviation 12.458
|
6.90 units on a scale
Standard Deviation 15.117
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 11
|
4.76 units on a scale
Standard Deviation 10.362
|
4.86 units on a scale
Standard Deviation 9.167
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 12
|
4.76 units on a scale
Standard Deviation 11.835
|
6.06 units on a scale
Standard Deviation 8.206
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 13
|
3.43 units on a scale
Standard Deviation 8.970
|
2.38 units on a scale
Standard Deviation 5.976
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 14
|
5.38 units on a scale
Standard Deviation 9.988
|
6.14 units on a scale
Standard Deviation 12.681
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 15
|
7.22 units on a scale
Standard Deviation 12.132
|
5.88 units on a scale
Standard Deviation 16.605
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 17
|
3.03 units on a scale
Standard Deviation 8.351
|
4.44 units on a scale
Standard Deviation 9.894
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 18
|
4.90 units on a scale
Standard Deviation 11.433
|
1.19 units on a scale
Standard Deviation 4.454
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 19
|
4.17 units on a scale
Standard Deviation 10.360
|
4.76 units on a scale
Standard Deviation 12.105
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 20
|
6.06 units on a scale
Standard Deviation 15.407
|
1.28 units on a scale
Standard Deviation 4.623
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 21
|
4.55 units on a scale
Standard Deviation 15.076
|
6.94 units on a scale
Standard Deviation 19.408
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 22
|
4.55 units on a scale
Standard Deviation 15.076
|
9.09 units on a scale
Standard Deviation 30.151
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 23
|
6.06 units on a scale
Standard Deviation 15.407
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 24
|
6.67 units on a scale
Standard Deviation 11.653
|
3.33 units on a scale
Standard Deviation 7.027
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 25
|
8.33 units on a scale
Standard Deviation 14.164
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 26
|
7.14 units on a scale
Standard Deviation 8.909
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 27
|
11.11 units on a scale
Standard Deviation 20.184
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 29
|
2.78 units on a scale
Standard Deviation 6.804
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 30
|
0.00 units on a scale
Standard Deviation 0.000
|
2.38 units on a scale
Standard Deviation 6.299
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 33
|
22.22 units on a scale
Standard Deviation 38.490
|
2.78 units on a scale
Standard Deviation 6.804
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 34
|
22.22 units on a scale
Standard Deviation 38.490
|
8.33 units on a scale
Standard Deviation 13.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 35
|
16.67 units on a scale
Standard Deviation 23.570
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 32
|
94.44 units on a scale
Standard Deviation 9.623
|
77.78 units on a scale
Standard Deviation 20.184
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
4.17 units on a scale
Standard Deviation 8.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 38
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Nausea and Vomiting: EOT
|
16.16 units on a scale
Standard Deviation 21.844
|
12.78 units on a scale
Standard Deviation 20.846
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 33
|
88.89 units on a scale
Standard Deviation 19.245
|
72.22 units on a scale
Standard Deviation 25.092
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 3
|
15.76 units on a scale
Standard Deviation 18.542
|
22.50 units on a scale
Standard Deviation 27.099
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 34
|
72.22 units on a scale
Standard Deviation 34.694
|
69.44 units on a scale
Standard Deviation 30.581
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 36
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
73.33 units on a scale
Standard Deviation 19.003
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 37
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
70.83 units on a scale
Standard Deviation 28.464
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 38
|
—
|
66.67 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 39
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
55.56 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 40
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
55.56 units on a scale
Standard Deviation 9.623
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 41
|
—
|
55.56 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 42
|
—
|
66.67 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: Cycle 43
|
—
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Role Functioning: EOT
|
70.71 units on a scale
Standard Deviation 26.031
|
65.56 units on a scale
Standard Deviation 36.075
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 1
|
80.19 units on a scale
Standard Deviation 18.644
|
76.23 units on a scale
Standard Deviation 18.238
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 2
|
84.31 units on a scale
Standard Deviation 17.619
|
77.64 units on a scale
Standard Deviation 17.021
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 3
|
82.53 units on a scale
Standard Deviation 18.792
|
73.96 units on a scale
Standard Deviation 24.401
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 4
|
82.67 units on a scale
Standard Deviation 16.906
|
77.41 units on a scale
Standard Deviation 22.167
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 5
|
82.09 units on a scale
Standard Deviation 18.632
|
79.66 units on a scale
Standard Deviation 21.141
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 6
|
82.17 units on a scale
Standard Deviation 17.871
|
73.92 units on a scale
Standard Deviation 24.696
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 8
|
80.63 units on a scale
Standard Deviation 21.877
|
76.00 units on a scale
Standard Deviation 18.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 9
|
80.24 units on a scale
Standard Deviation 19.812
|
76.92 units on a scale
Standard Deviation 18.304
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 10
|
81.27 units on a scale
Standard Deviation 19.818
|
76.45 units on a scale
Standard Deviation 21.998
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 11
|
79.76 units on a scale
Standard Deviation 19.311
|
75.46 units on a scale
Standard Deviation 20.587
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 12
|
78.10 units on a scale
Standard Deviation 23.052
|
75.76 units on a scale
Standard Deviation 22.700
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 13
|
77.45 units on a scale
Standard Deviation 22.429
|
77.38 units on a scale
Standard Deviation 19.211
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 14
|
78.49 units on a scale
Standard Deviation 20.387
|
75.00 units on a scale
Standard Deviation 24.375
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 15
|
80.00 units on a scale
Standard Deviation 21.173
|
74.51 units on a scale
Standard Deviation 23.839
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 17
|
79.92 units on a scale
Standard Deviation 23.522
|
79.44 units on a scale
Standard Deviation 19.382
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 20
|
71.21 units on a scale
Standard Deviation 29.666
|
78.85 units on a scale
Standard Deviation 25.823
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 21
|
76.52 units on a scale
Standard Deviation 28.824
|
75.00 units on a scale
Standard Deviation 25.624
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 23
|
74.24 units on a scale
Standard Deviation 30.834
|
75.00 units on a scale
Standard Deviation 27.778
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 24
|
71.67 units on a scale
Standard Deviation 28.921
|
76.67 units on a scale
Standard Deviation 22.153
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 25
|
65.83 units on a scale
Standard Deviation 33.206
|
66.67 units on a scale
Standard Deviation 29.881
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 26
|
71.43 units on a scale
Standard Deviation 34.979
|
77.38 units on a scale
Standard Deviation 17.156
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 27
|
56.94 units on a scale
Standard Deviation 32.667
|
68.75 units on a scale
Standard Deviation 29.124
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 28
|
65.48 units on a scale
Standard Deviation 34.166
|
68.75 units on a scale
Standard Deviation 29.463
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 29
|
68.33 units on a scale
Standard Deviation 29.698
|
71.43 units on a scale
Standard Deviation 31.127
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 30
|
72.92 units on a scale
Standard Deviation 29.950
|
70.24 units on a scale
Standard Deviation 31.497
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 31
|
45.83 units on a scale
Standard Deviation 17.678
|
72.62 units on a scale
Standard Deviation 26.227
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 32
|
69.44 units on a scale
Standard Deviation 29.266
|
69.44 units on a scale
Standard Deviation 33.610
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 33
|
77.78 units on a scale
Standard Deviation 19.245
|
70.83 units on a scale
Standard Deviation 27.764
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 34
|
66.67 units on a scale
Standard Deviation 33.333
|
66.67 units on a scale
Standard Deviation 34.561
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 35
|
83.33 units on a scale
Standard Deviation 23.570
|
68.06 units on a scale
Standard Deviation 33.918
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 36
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
71.67 units on a scale
Standard Deviation 31.513
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 38
|
—
|
70.83 units on a scale
Standard Deviation 42.219
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 40
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
66.67 units on a scale
Standard Deviation 38.188
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 41
|
—
|
58.33 units on a scale
Standard Deviation 41.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 42
|
—
|
54.17 units on a scale
Standard Deviation 64.818
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Emotional Functioning: Cycle 43
|
—
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 1
|
90.16 units on a scale
Standard Deviation 15.329
|
88.76 units on a scale
Standard Deviation 15.310
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 2
|
88.89 units on a scale
Standard Deviation 15.537
|
89.43 units on a scale
Standard Deviation 13.310
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 4
|
89.67 units on a scale
Standard Deviation 12.993
|
87.72 units on a scale
Standard Deviation 15.346
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 5
|
88.65 units on a scale
Standard Deviation 15.583
|
85.29 units on a scale
Standard Deviation 22.385
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 6
|
89.53 units on a scale
Standard Deviation 15.006
|
82.80 units on a scale
Standard Deviation 25.993
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 7
|
89.74 units on a scale
Standard Deviation 14.618
|
85.06 units on a scale
Standard Deviation 20.091
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 9
|
88.10 units on a scale
Standard Deviation 16.455
|
85.26 units on a scale
Standard Deviation 20.181
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 10
|
88.10 units on a scale
Standard Deviation 13.750
|
83.33 units on a scale
Standard Deviation 21.320
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 12
|
86.67 units on a scale
Standard Deviation 13.886
|
86.36 units on a scale
Standard Deviation 18.993
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 13
|
87.25 units on a scale
Standard Deviation 15.922
|
85.71 units on a scale
Standard Deviation 19.211
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 14
|
88.71 units on a scale
Standard Deviation 13.185
|
77.19 units on a scale
Standard Deviation 22.368
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 15
|
88.33 units on a scale
Standard Deviation 12.495
|
80.39 units on a scale
Standard Deviation 27.154
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 18
|
88.24 units on a scale
Standard Deviation 14.148
|
79.76 units on a scale
Standard Deviation 24.615
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 20
|
90.91 units on a scale
Standard Deviation 11.459
|
82.05 units on a scale
Standard Deviation 24.964
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 21
|
89.39 units on a scale
Standard Deviation 11.237
|
76.39 units on a scale
Standard Deviation 26.071
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 23
|
84.85 units on a scale
Standard Deviation 11.677
|
76.67 units on a scale
Standard Deviation 27.442
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 26
|
85.71 units on a scale
Standard Deviation 20.250
|
85.71 units on a scale
Standard Deviation 17.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 28
|
76.19 units on a scale
Standard Deviation 18.898
|
72.92 units on a scale
Standard Deviation 29.463
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 29
|
76.67 units on a scale
Standard Deviation 14.907
|
78.57 units on a scale
Standard Deviation 26.726
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 30
|
75.00 units on a scale
Standard Deviation 16.667
|
76.19 units on a scale
Standard Deviation 31.706
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 32
|
83.33 units on a scale
Standard Deviation 16.667
|
69.44 units on a scale
Standard Deviation 32.347
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 33
|
88.89 units on a scale
Standard Deviation 19.245
|
69.44 units on a scale
Standard Deviation 26.701
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 34
|
77.78 units on a scale
Standard Deviation 9.623
|
66.67 units on a scale
Standard Deviation 34.960
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 35
|
100.00 units on a scale
Standard Deviation 0.000
|
75.00 units on a scale
Standard Deviation 27.386
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 36
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
73.33 units on a scale
Standard Deviation 34.561
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 37
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
75.00 units on a scale
Standard Deviation 39.675
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 38
|
—
|
70.83 units on a scale
Standard Deviation 47.871
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 39
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
72.22 units on a scale
Standard Deviation 34.694
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 40
|
83.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
61.11 units on a scale
Standard Deviation 34.694
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 15
|
8.89 units on a scale
Standard Deviation 14.993
|
9.80 units on a scale
Standard Deviation 15.656
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 41
|
—
|
61.11 units on a scale
Standard Deviation 41.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 42
|
—
|
50.00 units on a scale
Standard Deviation 70.711
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: Cycle 43
|
—
|
100.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Cognitive Functioning: EOT
|
83.33 units on a scale
Standard Deviation 17.180
|
78.33 units on a scale
Standard Deviation 23.631
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 3
|
79.09 units on a scale
Standard Deviation 23.399
|
77.08 units on a scale
Standard Deviation 26.335
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 6
|
80.23 units on a scale
Standard Deviation 28.232
|
77.42 units on a scale
Standard Deviation 28.398
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 9
|
77.62 units on a scale
Standard Deviation 24.234
|
82.05 units on a scale
Standard Deviation 23.534
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 10
|
81.43 units on a scale
Standard Deviation 20.119
|
76.81 units on a scale
Standard Deviation 26.939
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 11
|
76.19 units on a scale
Standard Deviation 23.321
|
81.25 units on a scale
Standard Deviation 26.151
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 13
|
77.94 units on a scale
Standard Deviation 25.859
|
84.92 units on a scale
Standard Deviation 21.670
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Social Functioning: Cycle 14
|
81.18 units on a scale
Standard Deviation 20.968
|
79.82 units on a scale
Standard Deviation 29.700
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 19
|
0.00 units on a scale
Standard Deviation 0.000
|
9.52 units on a scale
Standard Deviation 20.375
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 21
|
0.00 units on a scale
Standard Deviation 0.000
|
2.78 units on a scale
Standard Deviation 9.623
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 23
|
0.00 units on a scale
Standard Deviation 0.000
|
3.33 units on a scale
Standard Deviation 10.541
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 24
|
0.00 units on a scale
Standard Deviation 0.000
|
6.67 units on a scale
Standard Deviation 14.055
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 9
|
20.48 units on a scale
Standard Deviation 19.838
|
19.87 units on a scale
Standard Deviation 19.447
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 30
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 10
|
19.52 units on a scale
Standard Deviation 22.682
|
18.84 units on a scale
Standard Deviation 22.079
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 11
|
19.05 units on a scale
Standard Deviation 19.446
|
13.89 units on a scale
Standard Deviation 18.169
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 32
|
0.00 units on a scale
Standard Deviation 0.000
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 13
|
17.16 units on a scale
Standard Deviation 15.616
|
15.87 units on a scale
Standard Deviation 20.053
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 15
|
15.00 units on a scale
Standard Deviation 23.305
|
21.57 units on a scale
Standard Deviation 24.127
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 35
|
0.00 units on a scale
Standard Deviation 0.000
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 16
|
17.28 units on a scale
Standard Deviation 21.917
|
15.63 units on a scale
Standard Deviation 14.232
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 17
|
18.94 units on a scale
Standard Deviation 23.171
|
15.56 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 18
|
16.67 units on a scale
Standard Deviation 22.048
|
10.71 units on a scale
Standard Deviation 16.803
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 19
|
26.39 units on a scale
Standard Deviation 27.941
|
13.10 units on a scale
Standard Deviation 16.249
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 22
|
18.18 units on a scale
Standard Deviation 26.304
|
21.21 units on a scale
Standard Deviation 21.201
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 24
|
28.33 units on a scale
Standard Deviation 26.117
|
20.00 units on a scale
Standard Deviation 24.595
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 25
|
26.67 units on a scale
Standard Deviation 30.631
|
16.67 units on a scale
Standard Deviation 19.920
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 26
|
38.10 units on a scale
Standard Deviation 40.500
|
16.67 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 29
|
19.44 units on a scale
Standard Deviation 19.484
|
23.81 units on a scale
Standard Deviation 26.972
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 34
|
22.22 units on a scale
Standard Deviation 38.490
|
27.78 units on a scale
Standard Deviation 25.092
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 35
|
25.00 units on a scale
Standard Deviation 35.355
|
22.22 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
20.00 units on a scale
Standard Deviation 13.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 38
|
—
|
29.17 units on a scale
Standard Deviation 28.464
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
38.89 units on a scale
Standard Deviation 25.459
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
44.44 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 41
|
—
|
55.56 units on a scale
Standard Deviation 41.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 42
|
—
|
33.33 units on a scale
Standard Deviation 47.140
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: Cycle 43
|
—
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Pain: EOT
|
23.74 units on a scale
Standard Deviation 25.695
|
33.89 units on a scale
Standard Deviation 32.009
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 1
|
5.00 units on a scale
Standard Deviation 12.003
|
7.58 units on a scale
Standard Deviation 15.854
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 2
|
7.02 units on a scale
Standard Deviation 15.088
|
8.73 units on a scale
Standard Deviation 18.123
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 3
|
6.06 units on a scale
Standard Deviation 12.975
|
9.17 units on a scale
Standard Deviation 21.334
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 5
|
5.67 units on a scale
Standard Deviation 14.445
|
10.78 units on a scale
Standard Deviation 22.801
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 6
|
6.98 units on a scale
Standard Deviation 15.530
|
10.75 units on a scale
Standard Deviation 24.925
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 8
|
15.32 units on a scale
Standard Deviation 21.652
|
6.67 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 9
|
9.52 units on a scale
Standard Deviation 20.725
|
5.13 units on a scale
Standard Deviation 12.265
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 10
|
9.52 units on a scale
Standard Deviation 15.278
|
10.14 units on a scale
Standard Deviation 21.165
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 11
|
5.71 units on a scale
Standard Deviation 12.746
|
9.72 units on a scale
Standard Deviation 15.477
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 12
|
8.57 units on a scale
Standard Deviation 14.781
|
6.06 units on a scale
Standard Deviation 13.159
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 13
|
10.78 units on a scale
Standard Deviation 15.829
|
12.70 units on a scale
Standard Deviation 19.653
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 14
|
9.68 units on a scale
Standard Deviation 15.380
|
8.77 units on a scale
Standard Deviation 15.080
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 16
|
6.17 units on a scale
Standard Deviation 13.195
|
6.25 units on a scale
Standard Deviation 13.437
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 17
|
10.61 units on a scale
Standard Deviation 15.891
|
6.67 units on a scale
Standard Deviation 13.801
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 18
|
7.84 units on a scale
Standard Deviation 14.575
|
4.76 units on a scale
Standard Deviation 12.105
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 19
|
13.89 units on a scale
Standard Deviation 17.164
|
4.76 units on a scale
Standard Deviation 12.105
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 22
|
9.09 units on a scale
Standard Deviation 15.570
|
9.09 units on a scale
Standard Deviation 15.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 23
|
6.06 units on a scale
Standard Deviation 13.484
|
13.33 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 24
|
6.67 units on a scale
Standard Deviation 14.055
|
13.33 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 25
|
13.33 units on a scale
Standard Deviation 23.307
|
8.33 units on a scale
Standard Deviation 15.430
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 26
|
9.52 units on a scale
Standard Deviation 16.265
|
9.52 units on a scale
Standard Deviation 16.265
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 27
|
11.11 units on a scale
Standard Deviation 27.217
|
8.33 units on a scale
Standard Deviation 15.430
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 28
|
19.05 units on a scale
Standard Deviation 17.817
|
12.50 units on a scale
Standard Deviation 17.252
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 29
|
11.11 units on a scale
Standard Deviation 27.217
|
19.05 units on a scale
Standard Deviation 17.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
9.52 units on a scale
Standard Deviation 16.265
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 32
|
11.11 units on a scale
Standard Deviation 19.245
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 33
|
22.22 units on a scale
Standard Deviation 38.490
|
11.11 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 35
|
16.67 units on a scale
Standard Deviation 23.570
|
11.11 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
26.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 38
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: EOT
|
10.10 units on a scale
Standard Deviation 19.516
|
3.33 units on a scale
Standard Deviation 10.171
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 1
|
14.21 units on a scale
Standard Deviation 22.327
|
11.63 units on a scale
Standard Deviation 17.644
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 41
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 42
|
—
|
16.67 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Dyspnoea: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 1
|
13.11 units on a scale
Standard Deviation 20.438
|
25.76 units on a scale
Standard Deviation 27.715
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 4
|
11.33 units on a scale
Standard Deviation 19.760
|
24.56 units on a scale
Standard Deviation 27.601
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 5
|
9.22 units on a scale
Standard Deviation 19.289
|
17.65 units on a scale
Standard Deviation 26.253
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 6
|
10.85 units on a scale
Standard Deviation 18.857
|
20.43 units on a scale
Standard Deviation 26.774
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 7
|
9.40 units on a scale
Standard Deviation 18.651
|
21.84 units on a scale
Standard Deviation 28.558
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 8
|
10.81 units on a scale
Standard Deviation 20.867
|
21.33 units on a scale
Standard Deviation 21.257
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 9
|
11.43 units on a scale
Standard Deviation 19.708
|
20.51 units on a scale
Standard Deviation 23.242
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 13
|
9.80 units on a scale
Standard Deviation 15.417
|
23.81 units on a scale
Standard Deviation 21.455
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 15
|
9.20 units on a scale
Standard Deviation 17.586
|
25.49 units on a scale
Standard Deviation 25.082
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 16
|
9.88 units on a scale
Standard Deviation 20.286
|
25.00 units on a scale
Standard Deviation 28.545
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 17
|
6.06 units on a scale
Standard Deviation 16.703
|
22.22 units on a scale
Standard Deviation 24.125
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 21
|
18.18 units on a scale
Standard Deviation 22.918
|
30.56 units on a scale
Standard Deviation 26.432
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 25
|
23.33 units on a scale
Standard Deviation 27.442
|
29.17 units on a scale
Standard Deviation 27.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 33
|
22.22 units on a scale
Standard Deviation 19.245
|
22.22 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 34
|
22.22 units on a scale
Standard Deviation 38.490
|
27.78 units on a scale
Standard Deviation 25.092
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 8
|
26.13 units on a scale
Standard Deviation 27.369
|
20.00 units on a scale
Standard Deviation 28.868
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
33.33 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Insomnia: Cycle 41
|
—
|
22.22 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 9
|
30.48 units on a scale
Standard Deviation 30.648
|
29.49 units on a scale
Standard Deviation 33.102
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 10
|
24.76 units on a scale
Standard Deviation 26.000
|
27.54 units on a scale
Standard Deviation 29.563
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 1
|
12.57 units on a scale
Standard Deviation 21.225
|
15.91 units on a scale
Standard Deviation 23.282
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 3
|
13.94 units on a scale
Standard Deviation 18.912
|
20.83 units on a scale
Standard Deviation 28.929
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 13
|
21.57 units on a scale
Standard Deviation 21.528
|
19.05 units on a scale
Standard Deviation 27.021
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 14
|
23.66 units on a scale
Standard Deviation 23.084
|
19.30 units on a scale
Standard Deviation 20.233
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 15
|
21.11 units on a scale
Standard Deviation 23.947
|
25.49 units on a scale
Standard Deviation 22.140
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 17
|
21.21 units on a scale
Standard Deviation 19.370
|
15.56 units on a scale
Standard Deviation 24.774
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 20
|
27.27 units on a scale
Standard Deviation 20.101
|
23.08 units on a scale
Standard Deviation 25.036
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 17
|
10.61 units on a scale
Standard Deviation 23.874
|
6.67 units on a scale
Standard Deviation 18.687
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 18
|
17.65 units on a scale
Standard Deviation 29.149
|
9.52 units on a scale
Standard Deviation 20.375
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 29
|
11.11 units on a scale
Standard Deviation 27.217
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
9.52 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 34
|
33.33 units on a scale
Standard Deviation 57.735
|
27.78 units on a scale
Standard Deviation 32.773
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 38
|
—
|
16.67 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 41
|
—
|
22.22 units on a scale
Standard Deviation 38.490
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 42
|
—
|
16.67 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Appetite Loss: EOT
|
27.27 units on a scale
Standard Deviation 34.816
|
26.67 units on a scale
Standard Deviation 32.044
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 1
|
7.10 units on a scale
Standard Deviation 17.336
|
9.09 units on a scale
Standard Deviation 18.135
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 11
|
3.81 units on a scale
Standard Deviation 13.459
|
2.78 units on a scale
Standard Deviation 9.411
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 13
|
2.94 units on a scale
Standard Deviation 9.597
|
1.59 units on a scale
Standard Deviation 7.274
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 14
|
1.08 units on a scale
Standard Deviation 5.987
|
3.51 units on a scale
Standard Deviation 10.510
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 15
|
2.22 units on a scale
Standard Deviation 8.457
|
3.92 units on a scale
Standard Deviation 16.169
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Constipation: Cycle 16
|
2.47 units on a scale
Standard Deviation 8.896
|
6.25 units on a scale
Standard Deviation 13.437
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 24
|
23.33 units on a scale
Standard Deviation 22.498
|
23.33 units on a scale
Standard Deviation 31.623
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 27
|
22.22 units on a scale
Standard Deviation 17.213
|
37.50 units on a scale
Standard Deviation 33.034
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 28
|
14.29 units on a scale
Standard Deviation 17.817
|
29.17 units on a scale
Standard Deviation 27.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
33.33 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
25.00 units on a scale
Standard Deviation 31.914
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 38
|
—
|
41.67 units on a scale
Standard Deviation 31.914
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 41
|
—
|
44.44 units on a scale
Standard Deviation 38.490
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 42
|
—
|
50.00 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Diarrhoea: Cycle 43
|
—
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 1
|
25.68 units on a scale
Standard Deviation 35.691
|
31.01 units on a scale
Standard Deviation 33.646
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 2
|
23.39 units on a scale
Standard Deviation 28.843
|
21.95 units on a scale
Standard Deviation 26.468
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 4
|
24.00 units on a scale
Standard Deviation 30.147
|
28.95 units on a scale
Standard Deviation 27.037
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 6
|
27.13 units on a scale
Standard Deviation 35.078
|
26.88 units on a scale
Standard Deviation 31.528
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 8
|
30.63 units on a scale
Standard Deviation 32.753
|
25.33 units on a scale
Standard Deviation 29.313
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 9
|
22.86 units on a scale
Standard Deviation 28.892
|
20.51 units on a scale
Standard Deviation 29.929
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 12
|
26.67 units on a scale
Standard Deviation 30.033
|
19.70 units on a scale
Standard Deviation 26.546
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 17
|
19.70 units on a scale
Standard Deviation 24.471
|
15.56 units on a scale
Standard Deviation 27.794
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 22
|
18.18 units on a scale
Standard Deviation 27.340
|
15.15 units on a scale
Standard Deviation 22.918
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 24
|
20.00 units on a scale
Standard Deviation 28.109
|
16.67 units on a scale
Standard Deviation 32.394
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 25
|
16.67 units on a scale
Standard Deviation 28.328
|
29.17 units on a scale
Standard Deviation 37.533
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 32
|
22.22 units on a scale
Standard Deviation 38.490
|
22.22 units on a scale
Standard Deviation 40.369
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 37
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 38
|
—
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Financial Difficulties: Cycle 40
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)Population: FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, "0 participants" in the "number analyzed" field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.
EORTC QLQ-GI-NET 21 was a 21-item questionnaire. These 21 questions assesses endocrine symptoms, gastrointestinal (G.I.) symptoms, treatment related symptoms, social functioning, disease related worries, muscle/bone pain, sexual function, information/communication function and body image. Each item was answered on a 4-point scale: 1 =not at all, 2 =a little, 3 =quite a bit, 4 =very much; where higher scores indicated more severe symptoms/problems. Scores averaged, transformed to 0-100 scale; higher score=more severe symptoms.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 30
|
20.37 units on a scale
Standard Deviation 3.208
|
15.87 units on a scale
Standard Deviation 14.138
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 32
|
16.67 units on a scale
Standard Deviation 5.556
|
20.37 units on a scale
Standard Deviation 7.590
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 42
|
—
|
27.78 units on a scale
Standard Deviation 7.857
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 34
|
27.78 units on a scale
Standard Deviation 9.623
|
20.37 units on a scale
Standard Deviation 12.989
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 3
|
14.75 units on a scale
Standard Deviation 20.066
|
11.67 units on a scale
Standard Deviation 14.443
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 4
|
12.67 units on a scale
Standard Deviation 15.227
|
12.31 units on a scale
Standard Deviation 14.531
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 6
|
13.18 units on a scale
Standard Deviation 16.490
|
9.32 units on a scale
Standard Deviation 13.788
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 8
|
13.81 units on a scale
Standard Deviation 18.408
|
10.67 units on a scale
Standard Deviation 14.515
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 9
|
10.16 units on a scale
Standard Deviation 14.851
|
11.11 units on a scale
Standard Deviation 14.741
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 10
|
10.16 units on a scale
Standard Deviation 13.304
|
14.01 units on a scale
Standard Deviation 18.416
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 11
|
13.02 units on a scale
Standard Deviation 16.934
|
13.43 units on a scale
Standard Deviation 19.653
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 12
|
12.06 units on a scale
Standard Deviation 16.693
|
11.62 units on a scale
Standard Deviation 17.644
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 14
|
12.19 units on a scale
Standard Deviation 16.815
|
14.62 units on a scale
Standard Deviation 18.538
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 17
|
12.12 units on a scale
Standard Deviation 18.753
|
8.89 units on a scale
Standard Deviation 10.457
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 18
|
11.11 units on a scale
Standard Deviation 18.840
|
11.90 units on a scale
Standard Deviation 14.756
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 19
|
14.81 units on a scale
Standard Deviation 21.364
|
6.35 units on a scale
Standard Deviation 11.293
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 23
|
18.18 units on a scale
Standard Deviation 15.131
|
13.33 units on a scale
Standard Deviation 16.397
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 25
|
16.67 units on a scale
Standard Deviation 23.570
|
8.33 units on a scale
Standard Deviation 12.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 26
|
22.22 units on a scale
Standard Deviation 27.962
|
7.94 units on a scale
Standard Deviation 13.929
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 27
|
22.22 units on a scale
Standard Deviation 28.109
|
9.72 units on a scale
Standard Deviation 12.511
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 29
|
12.96 units on a scale
Standard Deviation 12.989
|
11.11 units on a scale
Standard Deviation 12.830
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 30
|
8.89 units on a scale
Standard Deviation 9.296
|
14.29 units on a scale
Standard Deviation 13.929
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 31
|
14.81 units on a scale
Standard Deviation 6.415
|
12.70 units on a scale
Standard Deviation 11.878
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 32
|
7.41 units on a scale
Standard Deviation 12.830
|
14.81 units on a scale
Standard Deviation 13.456
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 33
|
11.11 units on a scale
Standard Deviation 0.000
|
16.67 units on a scale
Standard Deviation 11.653
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 34
|
18.52 units on a scale
Standard Deviation 6.415
|
20.37 units on a scale
Standard Deviation 23.744
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 35
|
22.22 units on a scale
Standard Deviation 0.000
|
16.67 units on a scale
Standard Deviation 16.851
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 36
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
17.78 units on a scale
Standard Deviation 18.592
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 37
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
5.56 units on a scale
Standard Deviation 11.111
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 38
|
—
|
8.33 units on a scale
Standard Deviation 10.638
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 39
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 11.111
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 40
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 11.111
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 41
|
—
|
11.11 units on a scale
Standard Deviation 11.111
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: EOT
|
13.80 units on a scale
Standard Deviation 15.474
|
11.11 units on a scale
Standard Deviation 16.534
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 1
|
15.41 units on a scale
Standard Deviation 14.633
|
15.30 units on a scale
Standard Deviation 13.301
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 2
|
17.66 units on a scale
Standard Deviation 14.057
|
17.72 units on a scale
Standard Deviation 13.631
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 3
|
20.24 units on a scale
Standard Deviation 17.543
|
19.50 units on a scale
Standard Deviation 16.702
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 4
|
19.47 units on a scale
Standard Deviation 16.814
|
19.30 units on a scale
Standard Deviation 17.315
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 5
|
15.18 units on a scale
Standard Deviation 13.528
|
21.01 units on a scale
Standard Deviation 17.569
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 6
|
18.76 units on a scale
Standard Deviation 16.982
|
21.51 units on a scale
Standard Deviation 20.273
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 7
|
18.63 units on a scale
Standard Deviation 19.114
|
20.23 units on a scale
Standard Deviation 18.728
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 8
|
20.72 units on a scale
Standard Deviation 19.359
|
19.47 units on a scale
Standard Deviation 15.743
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 9
|
18.86 units on a scale
Standard Deviation 18.040
|
19.49 units on a scale
Standard Deviation 17.681
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 10
|
18.38 units on a scale
Standard Deviation 17.916
|
19.78 units on a scale
Standard Deviation 18.315
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 11
|
18.86 units on a scale
Standard Deviation 15.295
|
16.94 units on a scale
Standard Deviation 17.360
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 12
|
18.86 units on a scale
Standard Deviation 18.040
|
18.79 units on a scale
Standard Deviation 20.741
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 13
|
18.04 units on a scale
Standard Deviation 17.641
|
14.60 units on a scale
Standard Deviation 13.600
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 14
|
18.06 units on a scale
Standard Deviation 18.871
|
16.49 units on a scale
Standard Deviation 13.943
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 15
|
19.56 units on a scale
Standard Deviation 17.934
|
22.35 units on a scale
Standard Deviation 22.966
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 16
|
17.53 units on a scale
Standard Deviation 17.458
|
17.50 units on a scale
Standard Deviation 14.782
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 17
|
18.18 units on a scale
Standard Deviation 19.099
|
13.78 units on a scale
Standard Deviation 12.206
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 19
|
23.89 units on a scale
Standard Deviation 21.360
|
20.48 units on a scale
Standard Deviation 20.500
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 21
|
29.09 units on a scale
Standard Deviation 22.759
|
17.22 units on a scale
Standard Deviation 16.927
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 22
|
23.03 units on a scale
Standard Deviation 21.574
|
18.18 units on a scale
Standard Deviation 18.641
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 23
|
27.27 units on a scale
Standard Deviation 26.408
|
20.00 units on a scale
Standard Deviation 18.856
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 24
|
26.00 units on a scale
Standard Deviation 20.476
|
21.33 units on a scale
Standard Deviation 18.539
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 25
|
24.67 units on a scale
Standard Deviation 19.386
|
23.33 units on a scale
Standard Deviation 17.090
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 26
|
30.48 units on a scale
Standard Deviation 17.152
|
20.95 units on a scale
Standard Deviation 15.601
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 29
|
22.22 units on a scale
Standard Deviation 5.443
|
28.57 units on a scale
Standard Deviation 17.090
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 30
|
18.67 units on a scale
Standard Deviation 15.202
|
21.90 units on a scale
Standard Deviation 17.518
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 32
|
22.22 units on a scale
Standard Deviation 27.756
|
27.78 units on a scale
Standard Deviation 19.052
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 33
|
26.67 units on a scale
Standard Deviation 35.277
|
23.33 units on a scale
Standard Deviation 17.256
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 34
|
20.00 units on a scale
Standard Deviation 29.059
|
28.89 units on a scale
Standard Deviation 15.587
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 35
|
23.33 units on a scale
Standard Deviation 32.998
|
20.00 units on a scale
Standard Deviation 15.202
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
17.33 units on a scale
Standard Deviation 15.348
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
21.67 units on a scale
Standard Deviation 13.744
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms:EOT
|
23.23 units on a scale
Standard Deviation 18.568
|
18.85 units on a scale
Standard Deviation 19.766
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 2
|
14.48 units on a scale
Standard Deviation 11.686
|
16.20 units on a scale
Standard Deviation 14.141
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 3
|
15.42 units on a scale
Standard Deviation 12.280
|
17.09 units on a scale
Standard Deviation 18.574
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 6
|
15.45 units on a scale
Standard Deviation 13.293
|
15.00 units on a scale
Standard Deviation 17.577
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 10
|
15.99 units on a scale
Standard Deviation 15.760
|
16.91 units on a scale
Standard Deviation 17.446
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 16
|
13.78 units on a scale
Standard Deviation 13.714
|
10.74 units on a scale
Standard Deviation 14.467
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 18
|
17.71 units on a scale
Standard Deviation 16.999
|
10.71 units on a scale
Standard Deviation 11.828
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 19
|
20.00 units on a scale
Standard Deviation 17.013
|
12.30 units on a scale
Standard Deviation 13.287
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 21
|
18.18 units on a scale
Standard Deviation 18.608
|
14.81 units on a scale
Standard Deviation 14.279
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 26
|
26.19 units on a scale
Standard Deviation 21.448
|
12.70 units on a scale
Standard Deviation 11.437
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 27
|
37.96 units on a scale
Standard Deviation 16.636
|
19.44 units on a scale
Standard Deviation 18.306
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 28
|
35.56 units on a scale
Standard Deviation 21.009
|
17.36 units on a scale
Standard Deviation 15.555
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 43
|
—
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: EOT
|
24.33 units on a scale
Standard Deviation 20.542
|
20.78 units on a scale
Standard Deviation 24.969
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 6
|
25.71 units on a scale
Standard Deviation 21.138
|
28.32 units on a scale
Standard Deviation 23.101
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 8
|
30.63 units on a scale
Standard Deviation 20.015
|
27.11 units on a scale
Standard Deviation 20.051
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 12
|
28.25 units on a scale
Standard Deviation 24.454
|
23.74 units on a scale
Standard Deviation 22.562
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 15
|
28.52 units on a scale
Standard Deviation 20.149
|
28.76 units on a scale
Standard Deviation 28.070
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 16
|
27.16 units on a scale
Standard Deviation 20.286
|
27.78 units on a scale
Standard Deviation 23.307
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 24
|
38.89 units on a scale
Standard Deviation 28.328
|
24.44 units on a scale
Standard Deviation 24.456
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 25
|
35.56 units on a scale
Standard Deviation 27.116
|
31.94 units on a scale
Standard Deviation 26.184
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 26
|
46.03 units on a scale
Standard Deviation 28.276
|
22.22 units on a scale
Standard Deviation 11.111
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 28
|
46.03 units on a scale
Standard Deviation 33.597
|
31.94 units on a scale
Standard Deviation 29.360
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 29
|
35.19 units on a scale
Standard Deviation 25.740
|
28.57 units on a scale
Standard Deviation 27.857
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 35
|
38.89 units on a scale
Standard Deviation 23.570
|
33.33 units on a scale
Standard Deviation 24.343
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 36
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
31.11 units on a scale
Standard Deviation 27.666
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 39
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
51.85 units on a scale
Standard Deviation 44.905
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 42
|
—
|
38.89 units on a scale
Standard Deviation 39.284
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: EOT
|
39.73 units on a scale
Standard Deviation 25.914
|
41.38 units on a scale
Standard Deviation 26.874
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 3
|
36.46 units on a scale
Standard Deviation 23.074
|
34.58 units on a scale
Standard Deviation 23.853
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 6
|
36.43 units on a scale
Standard Deviation 25.148
|
34.05 units on a scale
Standard Deviation 25.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 9
|
35.71 units on a scale
Standard Deviation 31.116
|
32.05 units on a scale
Standard Deviation 22.072
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 10
|
37.30 units on a scale
Standard Deviation 26.458
|
28.02 units on a scale
Standard Deviation 26.563
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 11
|
35.87 units on a scale
Standard Deviation 25.292
|
27.78 units on a scale
Standard Deviation 22.700
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 17
|
29.80 units on a scale
Standard Deviation 22.059
|
34.07 units on a scale
Standard Deviation 27.043
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 18
|
30.07 units on a scale
Standard Deviation 28.805
|
32.14 units on a scale
Standard Deviation 27.232
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 19
|
37.50 units on a scale
Standard Deviation 29.504
|
31.75 units on a scale
Standard Deviation 28.862
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 20
|
40.40 units on a scale
Standard Deviation 32.687
|
29.91 units on a scale
Standard Deviation 31.877
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 22
|
33.33 units on a scale
Standard Deviation 31.032
|
30.30 units on a scale
Standard Deviation 34.816
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 27
|
52.78 units on a scale
Standard Deviation 40.023
|
34.72 units on a scale
Standard Deviation 28.133
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 31
|
48.15 units on a scale
Standard Deviation 46.259
|
36.51 units on a scale
Standard Deviation 32.530
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 32
|
25.93 units on a scale
Standard Deviation 23.130
|
37.04 units on a scale
Standard Deviation 38.276
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 33
|
51.85 units on a scale
Standard Deviation 42.066
|
35.19 units on a scale
Standard Deviation 36.118
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 35
|
16.67 units on a scale
Standard Deviation 23.570
|
35.19 units on a scale
Standard Deviation 34.006
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
31.11 units on a scale
Standard Deviation 36.345
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 6
|
18.60 units on a scale
Standard Deviation 20.959
|
20.43 units on a scale
Standard Deviation 23.847
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 7
|
20.51 units on a scale
Standard Deviation 22.446
|
21.84 units on a scale
Standard Deviation 29.915
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 9
|
16.19 units on a scale
Standard Deviation 18.737
|
20.51 units on a scale
Standard Deviation 21.243
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 10
|
20.00 units on a scale
Standard Deviation 25.820
|
24.64 units on a scale
Standard Deviation 28.810
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 12
|
20.95 units on a scale
Standard Deviation 26.918
|
19.70 units on a scale
Standard Deviation 24.471
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 13
|
20.59 units on a scale
Standard Deviation 24.638
|
23.81 units on a scale
Standard Deviation 28.172
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 14
|
12.90 units on a scale
Standard Deviation 22.240
|
22.81 units on a scale
Standard Deviation 27.336
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 17
|
22.73 units on a scale
Standard Deviation 25.996
|
15.56 units on a scale
Standard Deviation 24.774
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 19
|
25.00 units on a scale
Standard Deviation 20.719
|
16.67 units on a scale
Standard Deviation 25.318
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 21
|
21.21 units on a scale
Standard Deviation 22.473
|
13.89 units on a scale
Standard Deviation 22.285
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 22
|
15.15 units on a scale
Standard Deviation 22.918
|
24.24 units on a scale
Standard Deviation 26.208
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 23
|
21.21 units on a scale
Standard Deviation 26.968
|
23.33 units on a scale
Standard Deviation 22.498
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 26
|
33.33 units on a scale
Standard Deviation 27.217
|
28.57 units on a scale
Standard Deviation 29.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 29
|
22.22 units on a scale
Standard Deviation 27.217
|
33.33 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 31
|
22.22 units on a scale
Standard Deviation 38.490
|
38.10 units on a scale
Standard Deviation 29.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
44.44 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 40
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
55.56 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 41
|
—
|
55.56 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 43
|
—
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 7
|
19.05 units on a scale
Standard Deviation 24.727
|
30.43 units on a scale
Standard Deviation 37.488
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 9
|
13.33 units on a scale
Standard Deviation 27.217
|
28.07 units on a scale
Standard Deviation 31.940
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 10
|
17.33 units on a scale
Standard Deviation 29.059
|
27.08 units on a scale
Standard Deviation 32.702
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 17
|
20.00 units on a scale
Standard Deviation 27.603
|
22.22 units on a scale
Standard Deviation 25.950
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 21
|
23.81 units on a scale
Standard Deviation 25.198
|
14.81 units on a scale
Standard Deviation 24.216
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 27
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 28
|
33.33 units on a scale
Standard Deviation 33.333
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 30
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 32
|
22.22 units on a scale
Standard Deviation 38.490
|
20.00 units on a scale
Standard Deviation 29.814
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 33
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
20.00 units on a scale
Standard Deviation 29.814
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 34
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
33.33 units on a scale
Standard Deviation 33.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 35
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
20.00 units on a scale
Standard Deviation 29.814
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
25.00 units on a scale
Standard Deviation 31.914
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
33.33 units on a scale
Standard Deviation 33.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 40
|
66.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 41
|
—
|
16.67 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 3
|
5.45 units on a scale
Standard Deviation 14.001
|
5.00 units on a scale
Standard Deviation 14.222
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 4
|
4.67 units on a scale
Standard Deviation 11.684
|
5.26 units on a scale
Standard Deviation 12.318
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 24
|
10.00 units on a scale
Standard Deviation 22.498
|
3.33 units on a scale
Standard Deviation 10.541
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 1
|
21.67 units on a scale
Standard Deviation 32.950
|
24.24 units on a scale
Standard Deviation 24.234
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 8
|
13.51 units on a scale
Standard Deviation 24.164
|
15.28 units on a scale
Standard Deviation 24.035
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 38
|
—
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 7
|
18.77 units on a scale
Standard Deviation 16.216
|
15.84 units on a scale
Standard Deviation 17.207
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 8
|
20.48 units on a scale
Standard Deviation 19.930
|
14.12 units on a scale
Standard Deviation 17.870
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 9
|
18.23 units on a scale
Standard Deviation 15.917
|
14.01 units on a scale
Standard Deviation 17.558
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 20
|
15.15 units on a scale
Standard Deviation 20.045
|
11.11 units on a scale
Standard Deviation 17.568
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 21
|
20.20 units on a scale
Standard Deviation 20.975
|
9.26 units on a scale
Standard Deviation 12.385
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 18
|
24.31 units on a scale
Standard Deviation 20.942
|
15.71 units on a scale
Standard Deviation 12.433
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 20
|
25.45 units on a scale
Standard Deviation 22.473
|
16.41 units on a scale
Standard Deviation 15.303
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 27
|
34.44 units on a scale
Standard Deviation 28.415
|
25.83 units on a scale
Standard Deviation 20.912
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 28
|
28.57 units on a scale
Standard Deviation 23.637
|
23.96 units on a scale
Standard Deviation 20.967
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 31
|
24.44 units on a scale
Standard Deviation 26.943
|
22.86 units on a scale
Standard Deviation 19.572
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 38
|
—
|
27.92 units on a scale
Standard Deviation 20.520
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 39
|
6.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
31.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
26.67 units on a scale
Standard Deviation 17.638
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 41
|
—
|
35.56 units on a scale
Standard Deviation 21.430
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 42
|
—
|
33.33 units on a scale
Standard Deviation 18.856
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 1
|
9.47 units on a scale
Standard Deviation 14.746
|
15.66 units on a scale
Standard Deviation 20.378
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 2
|
9.94 units on a scale
Standard Deviation 14.347
|
14.91 units on a scale
Standard Deviation 16.407
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Gastrointestinal Symptoms: Cycle 43
|
—
|
20.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 5
|
12.29 units on a scale
Standard Deviation 13.752
|
8.08 units on a scale
Standard Deviation 12.507
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 7
|
12.82 units on a scale
Standard Deviation 14.315
|
12.07 units on a scale
Standard Deviation 16.538
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 1
|
12.57 units on a scale
Standard Deviation 14.797
|
16.24 units on a scale
Standard Deviation 19.038
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 4
|
17.53 units on a scale
Standard Deviation 15.622
|
13.89 units on a scale
Standard Deviation 16.074
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 5
|
15.06 units on a scale
Standard Deviation 11.522
|
14.52 units on a scale
Standard Deviation 15.361
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 13
|
10.46 units on a scale
Standard Deviation 14.459
|
11.64 units on a scale
Standard Deviation 15.899
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 15
|
13.33 units on a scale
Standard Deviation 18.082
|
15.69 units on a scale
Standard Deviation 18.864
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 16
|
10.70 units on a scale
Standard Deviation 16.155
|
9.03 units on a scale
Standard Deviation 11.631
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 11
|
16.83 units on a scale
Standard Deviation 16.196
|
15.05 units on a scale
Standard Deviation 21.453
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 12
|
16.01 units on a scale
Standard Deviation 18.989
|
11.11 units on a scale
Standard Deviation 13.494
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 22
|
14.14 units on a scale
Standard Deviation 19.303
|
16.16 units on a scale
Standard Deviation 21.294
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 13
|
15.45 units on a scale
Standard Deviation 12.441
|
7.89 units on a scale
Standard Deviation 8.942
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 14
|
13.60 units on a scale
Standard Deviation 12.386
|
11.70 units on a scale
Standard Deviation 13.968
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 24
|
22.22 units on a scale
Standard Deviation 31.427
|
13.33 units on a scale
Standard Deviation 14.628
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 15
|
15.48 units on a scale
Standard Deviation 12.950
|
8.68 units on a scale
Standard Deviation 12.664
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 17
|
14.81 units on a scale
Standard Deviation 15.941
|
7.41 units on a scale
Standard Deviation 8.572
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Endocrine Symptoms: Cycle 28
|
19.05 units on a scale
Standard Deviation 29.197
|
12.50 units on a scale
Standard Deviation 18.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 20
|
18.33 units on a scale
Standard Deviation 17.382
|
9.72 units on a scale
Standard Deviation 11.392
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 22
|
24.44 units on a scale
Standard Deviation 22.253
|
12.63 units on a scale
Standard Deviation 12.691
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 23
|
22.22 units on a scale
Standard Deviation 23.570
|
13.89 units on a scale
Standard Deviation 13.671
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 24
|
22.84 units on a scale
Standard Deviation 24.602
|
11.67 units on a scale
Standard Deviation 13.969
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 25
|
21.53 units on a scale
Standard Deviation 21.504
|
15.28 units on a scale
Standard Deviation 14.164
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 29
|
16.67 units on a scale
Standard Deviation 4.536
|
15.87 units on a scale
Standard Deviation 12.184
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 31
|
22.22 units on a scale
Standard Deviation 11.111
|
20.63 units on a scale
Standard Deviation 17.484
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 33
|
22.22 units on a scale
Standard Deviation 11.111
|
20.37 units on a scale
Standard Deviation 7.590
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 35
|
11.11 units on a scale
Standard Deviation 15.713
|
17.59 units on a scale
Standard Deviation 11.340
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 36
|
16.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
25.56 units on a scale
Standard Deviation 7.454
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 37
|
16.67 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
26.39 units on a scale
Standard Deviation 8.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 38
|
—
|
22.22 units on a scale
Standard Deviation 11.111
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
29.63 units on a scale
Standard Deviation 6.415
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
25.93 units on a scale
Standard Deviation 6.415
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Treatment Related Symptoms: Cycle 41
|
—
|
24.07 units on a scale
Standard Deviation 8.486
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 1
|
35.34 units on a scale
Standard Deviation 22.907
|
31.06 units on a scale
Standard Deviation 20.132
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 2
|
30.99 units on a scale
Standard Deviation 21.490
|
29.81 units on a scale
Standard Deviation 22.695
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 3
|
29.49 units on a scale
Standard Deviation 20.534
|
30.00 units on a scale
Standard Deviation 25.061
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 4
|
27.00 units on a scale
Standard Deviation 19.441
|
26.17 units on a scale
Standard Deviation 22.331
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 5
|
27.90 units on a scale
Standard Deviation 19.087
|
24.24 units on a scale
Standard Deviation 22.473
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 7
|
29.06 units on a scale
Standard Deviation 20.171
|
27.20 units on a scale
Standard Deviation 26.157
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 9
|
29.84 units on a scale
Standard Deviation 27.715
|
23.08 units on a scale
Standard Deviation 19.607
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 10
|
28.89 units on a scale
Standard Deviation 22.579
|
24.64 units on a scale
Standard Deviation 24.835
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 11
|
29.21 units on a scale
Standard Deviation 21.573
|
24.07 units on a scale
Standard Deviation 22.383
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 13
|
24.84 units on a scale
Standard Deviation 23.380
|
23.81 units on a scale
Standard Deviation 23.382
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 14
|
27.96 units on a scale
Standard Deviation 20.056
|
25.73 units on a scale
Standard Deviation 24.018
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 17
|
28.79 units on a scale
Standard Deviation 21.320
|
23.70 units on a scale
Standard Deviation 22.564
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 18
|
29.41 units on a scale
Standard Deviation 26.040
|
26.98 units on a scale
Standard Deviation 21.666
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 19
|
29.63 units on a scale
Standard Deviation 25.219
|
28.57 units on a scale
Standard Deviation 22.943
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 20
|
31.82 units on a scale
Standard Deviation 28.119
|
29.06 units on a scale
Standard Deviation 28.160
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 21
|
35.35 units on a scale
Standard Deviation 30.151
|
24.07 units on a scale
Standard Deviation 23.130
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 22
|
31.31 units on a scale
Standard Deviation 28.029
|
27.27 units on a scale
Standard Deviation 24.527
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 23
|
30.30 units on a scale
Standard Deviation 28.149
|
26.67 units on a scale
Standard Deviation 27.317
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 27
|
51.85 units on a scale
Standard Deviation 28.689
|
33.33 units on a scale
Standard Deviation 28.483
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 30
|
35.56 units on a scale
Standard Deviation 26.527
|
30.16 units on a scale
Standard Deviation 29.893
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 31
|
44.44 units on a scale
Standard Deviation 22.222
|
30.16 units on a scale
Standard Deviation 29.197
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 32
|
33.33 units on a scale
Standard Deviation 11.111
|
31.48 units on a scale
Standard Deviation 30.965
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 33
|
40.74 units on a scale
Standard Deviation 23.130
|
40.74 units on a scale
Standard Deviation 31.164
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 34
|
44.44 units on a scale
Standard Deviation 22.222
|
35.19 units on a scale
Standard Deviation 29.327
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 37
|
22.22 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
30.56 units on a scale
Standard Deviation 39.933
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 38
|
—
|
41.67 units on a scale
Standard Deviation 41.944
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 40
|
11.11 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
42.59 units on a scale
Standard Deviation 36.991
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 41
|
—
|
44.44 units on a scale
Standard Deviation 40.062
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Social Functioning: Cycle 43
|
—
|
11.11 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 1
|
49.27 units on a scale
Standard Deviation 26.381
|
42.89 units on a scale
Standard Deviation 23.108
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 2
|
38.01 units on a scale
Standard Deviation 24.550
|
36.04 units on a scale
Standard Deviation 24.942
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 4
|
31.89 units on a scale
Standard Deviation 22.075
|
33.19 units on a scale
Standard Deviation 23.904
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 5
|
37.12 units on a scale
Standard Deviation 25.619
|
30.64 units on a scale
Standard Deviation 22.742
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 7
|
39.32 units on a scale
Standard Deviation 24.825
|
32.18 units on a scale
Standard Deviation 26.618
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 8
|
38.29 units on a scale
Standard Deviation 25.653
|
32.00 units on a scale
Standard Deviation 22.753
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 12
|
35.56 units on a scale
Standard Deviation 28.621
|
29.29 units on a scale
Standard Deviation 25.325
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 13
|
34.64 units on a scale
Standard Deviation 27.046
|
30.16 units on a scale
Standard Deviation 24.881
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 14
|
32.97 units on a scale
Standard Deviation 22.312
|
31.87 units on a scale
Standard Deviation 22.055
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 15
|
34.44 units on a scale
Standard Deviation 25.160
|
33.66 units on a scale
Standard Deviation 27.250
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 16
|
34.16 units on a scale
Standard Deviation 25.022
|
37.85 units on a scale
Standard Deviation 23.589
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 21
|
39.90 units on a scale
Standard Deviation 30.512
|
27.78 units on a scale
Standard Deviation 30.887
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 23
|
36.36 units on a scale
Standard Deviation 35.168
|
26.11 units on a scale
Standard Deviation 29.403
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 24
|
41.11 units on a scale
Standard Deviation 32.309
|
27.78 units on a scale
Standard Deviation 28.328
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 25
|
38.33 units on a scale
Standard Deviation 32.547
|
38.89 units on a scale
Standard Deviation 31.983
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 26
|
42.86 units on a scale
Standard Deviation 33.597
|
31.75 units on a scale
Standard Deviation 33.597
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 28
|
50.79 units on a scale
Standard Deviation 38.946
|
40.28 units on a scale
Standard Deviation 39.368
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 29
|
37.96 units on a scale
Standard Deviation 35.210
|
38.10 units on a scale
Standard Deviation 35.635
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 30
|
35.56 units on a scale
Standard Deviation 38.809
|
34.92 units on a scale
Standard Deviation 29.696
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 34
|
55.56 units on a scale
Standard Deviation 40.062
|
35.19 units on a scale
Standard Deviation 36.796
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
22.22 units on a scale
Standard Deviation 31.427
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 38
|
—
|
33.33 units on a scale
Standard Deviation 45.361
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
44.44 units on a scale
Standard Deviation 50.918
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
37.04 units on a scale
Standard Deviation 35.717
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 41
|
—
|
44.44 units on a scale
Standard Deviation 50.918
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 42
|
—
|
50.00 units on a scale
Standard Deviation 54.997
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Disease Related Worries: EOT
|
50.84 units on a scale
Standard Deviation 27.079
|
41.38 units on a scale
Standard Deviation 30.123
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 1
|
13.56 units on a scale
Standard Deviation 20.640
|
13.64 units on a scale
Standard Deviation 20.734
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 2
|
20.47 units on a scale
Standard Deviation 24.197
|
17.89 units on a scale
Standard Deviation 23.685
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 3
|
16.36 units on a scale
Standard Deviation 19.108
|
23.33 units on a scale
Standard Deviation 24.108
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 4
|
16.00 units on a scale
Standard Deviation 20.471
|
21.93 units on a scale
Standard Deviation 26.024
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 5
|
17.02 units on a scale
Standard Deviation 18.221
|
22.22 units on a scale
Standard Deviation 27.217
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 8
|
20.72 units on a scale
Standard Deviation 22.705
|
20.00 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 11
|
21.90 units on a scale
Standard Deviation 25.492
|
22.22 units on a scale
Standard Deviation 25.380
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 15
|
11.49 units on a scale
Standard Deviation 18.422
|
25.49 units on a scale
Standard Deviation 32.338
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 16
|
19.75 units on a scale
Standard Deviation 24.909
|
16.67 units on a scale
Standard Deviation 24.343
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 18
|
15.69 units on a scale
Standard Deviation 20.809
|
14.29 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 20
|
27.27 units on a scale
Standard Deviation 25.025
|
12.82 units on a scale
Standard Deviation 21.681
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 24
|
20.00 units on a scale
Standard Deviation 23.307
|
30.00 units on a scale
Standard Deviation 29.187
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 25
|
23.33 units on a scale
Standard Deviation 27.442
|
33.33 units on a scale
Standard Deviation 30.861
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 27
|
50.00 units on a scale
Standard Deviation 18.257
|
29.17 units on a scale
Standard Deviation 27.817
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 28
|
38.10 units on a scale
Standard Deviation 23.002
|
33.33 units on a scale
Standard Deviation 35.635
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 30
|
26.67 units on a scale
Standard Deviation 27.889
|
28.57 units on a scale
Standard Deviation 35.635
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 32
|
22.22 units on a scale
Standard Deviation 38.490
|
38.89 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 33
|
33.33 units on a scale
Standard Deviation 33.333
|
33.33 units on a scale
Standard Deviation 29.814
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 34
|
11.11 units on a scale
Standard Deviation 19.245
|
44.44 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 35
|
33.33 units on a scale
Standard Deviation 47.140
|
38.89 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
53.33 units on a scale
Standard Deviation 18.257
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
50.00 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 38
|
—
|
58.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: Cycle 42
|
—
|
50.00 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Muscle/Bone Pain Symptom: EOT
|
25.25 units on a scale
Standard Deviation 27.677
|
26.44 units on a scale
Standard Deviation 30.052
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 1
|
22.55 units on a scale
Standard Deviation 31.485
|
34.48 units on a scale
Standard Deviation 35.054
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 2
|
17.83 units on a scale
Standard Deviation 25.561
|
30.00 units on a scale
Standard Deviation 30.763
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 3
|
17.95 units on a scale
Standard Deviation 25.185
|
36.78 units on a scale
Standard Deviation 32.544
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 4
|
18.63 units on a scale
Standard Deviation 24.878
|
22.22 units on a scale
Standard Deviation 30.662
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 5
|
18.75 units on a scale
Standard Deviation 25.312
|
28.40 units on a scale
Standard Deviation 35.450
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 6
|
14.44 units on a scale
Standard Deviation 20.869
|
31.88 units on a scale
Standard Deviation 35.503
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 8
|
23.08 units on a scale
Standard Deviation 27.919
|
27.08 units on a scale
Standard Deviation 27.806
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 11
|
16.00 units on a scale
Standard Deviation 25.676
|
20.83 units on a scale
Standard Deviation 26.874
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 12
|
20.51 units on a scale
Standard Deviation 29.929
|
19.05 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 13
|
16.67 units on a scale
Standard Deviation 26.006
|
22.22 units on a scale
Standard Deviation 32.530
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 14
|
20.00 units on a scale
Standard Deviation 27.217
|
26.19 units on a scale
Standard Deviation 26.726
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 15
|
17.46 units on a scale
Standard Deviation 27.119
|
19.44 units on a scale
Standard Deviation 26.432
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 16
|
22.81 units on a scale
Standard Deviation 33.431
|
25.64 units on a scale
Standard Deviation 27.735
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 18
|
22.22 units on a scale
Standard Deviation 21.711
|
18.18 units on a scale
Standard Deviation 27.340
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 19
|
19.05 units on a scale
Standard Deviation 26.227
|
20.00 units on a scale
Standard Deviation 28.109
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 20
|
25.00 units on a scale
Standard Deviation 29.547
|
13.33 units on a scale
Standard Deviation 23.307
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 22
|
33.33 units on a scale
Standard Deviation 30.861
|
14.81 units on a scale
Standard Deviation 24.216
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 23
|
23.81 units on a scale
Standard Deviation 31.706
|
20.83 units on a scale
Standard Deviation 24.801
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 24
|
26.67 units on a scale
Standard Deviation 27.889
|
16.67 units on a scale
Standard Deviation 25.198
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 25
|
26.67 units on a scale
Standard Deviation 36.515
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 26
|
25.00 units on a scale
Standard Deviation 31.914
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 29
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 31
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 27.889
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 38
|
—
|
33.33 units on a scale
Standard Deviation 33.333
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 39
|
33.33 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
16.67 units on a scale
Standard Deviation 23.570
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Sexual Function: EOT
|
25.76 units on a scale
Standard Deviation 27.084
|
49.12 units on a scale
Standard Deviation 37.463
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 1
|
8.74 units on a scale
Standard Deviation 21.860
|
6.82 units on a scale
Standard Deviation 15.384
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 2
|
5.85 units on a scale
Standard Deviation 12.791
|
5.69 units on a scale
Standard Deviation 14.724
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 5
|
3.55 units on a scale
Standard Deviation 10.389
|
7.07 units on a scale
Standard Deviation 18.177
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 6
|
4.65 units on a scale
Standard Deviation 11.687
|
5.38 units on a scale
Standard Deviation 15.146
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 7
|
6.84 units on a scale
Standard Deviation 13.636
|
9.20 units on a scale
Standard Deviation 23.395
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 8
|
8.11 units on a scale
Standard Deviation 16.491
|
5.33 units on a scale
Standard Deviation 15.753
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 9
|
5.71 units on a scale
Standard Deviation 12.746
|
3.85 units on a scale
Standard Deviation 10.860
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 10
|
8.57 units on a scale
Standard Deviation 16.848
|
7.25 units on a scale
Standard Deviation 17.281
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 11
|
7.62 units on a scale
Standard Deviation 18.232
|
5.56 units on a scale
Standard Deviation 16.051
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 12
|
10.48 units on a scale
Standard Deviation 22.537
|
1.52 units on a scale
Standard Deviation 7.107
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 13
|
3.92 units on a scale
Standard Deviation 10.901
|
4.76 units on a scale
Standard Deviation 11.952
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 14
|
6.45 units on a scale
Standard Deviation 13.387
|
3.51 units on a scale
Standard Deviation 10.510
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 15
|
4.44 units on a scale
Standard Deviation 11.525
|
7.84 units on a scale
Standard Deviation 18.743
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 16
|
2.47 units on a scale
Standard Deviation 8.896
|
8.33 units on a scale
Standard Deviation 14.907
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 17
|
4.55 units on a scale
Standard Deviation 11.708
|
2.22 units on a scale
Standard Deviation 8.607
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 18
|
7.84 units on a scale
Standard Deviation 14.575
|
7.14 units on a scale
Standard Deviation 19.298
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 19
|
0.00 units on a scale
Standard Deviation 0.000
|
2.38 units on a scale
Standard Deviation 8.909
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 20
|
3.03 units on a scale
Standard Deviation 10.050
|
2.56 units on a scale
Standard Deviation 9.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 21
|
6.06 units on a scale
Standard Deviation 13.484
|
2.78 units on a scale
Standard Deviation 9.623
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 22
|
6.06 units on a scale
Standard Deviation 13.484
|
3.03 units on a scale
Standard Deviation 10.050
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 23
|
9.09 units on a scale
Standard Deviation 21.556
|
3.33 units on a scale
Standard Deviation 10.541
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 25
|
6.67 units on a scale
Standard Deviation 14.055
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 26
|
11.11 units on a scale
Standard Deviation 17.213
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 27
|
0.00 units on a scale
Standard Deviation 0.000
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 28
|
9.52 units on a scale
Standard Deviation 16.265
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 29
|
5.56 units on a scale
Standard Deviation 13.608
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 30
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 32
|
0.00 units on a scale
Standard Deviation 0.000
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 33
|
11.11 units on a scale
Standard Deviation 19.245
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 34
|
11.11 units on a scale
Standard Deviation 19.245
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 35
|
0.00 units on a scale
Standard Deviation 0.000
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 38
|
—
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 40
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 41
|
—
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Information/Communication: EOT
|
10.10 units on a scale
Standard Deviation 19.516
|
5.75 units on a scale
Standard Deviation 20.057
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 2
|
12.87 units on a scale
Standard Deviation 19.674
|
15.45 units on a scale
Standard Deviation 25.925
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 3
|
10.90 units on a scale
Standard Deviation 21.614
|
19.17 units on a scale
Standard Deviation 31.020
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 4
|
10.88 units on a scale
Standard Deviation 17.197
|
16.67 units on a scale
Standard Deviation 24.199
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 5
|
8.70 units on a scale
Standard Deviation 17.826
|
15.15 units on a scale
Standard Deviation 25.126
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 6
|
11.90 units on a scale
Standard Deviation 21.866
|
21.11 units on a scale
Standard Deviation 29.664
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 7
|
14.91 units on a scale
Standard Deviation 25.347
|
21.43 units on a scale
Standard Deviation 31.706
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 9
|
14.29 units on a scale
Standard Deviation 28.337
|
14.67 units on a scale
Standard Deviation 23.727
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 10
|
13.73 units on a scale
Standard Deviation 24.779
|
18.84 units on a scale
Standard Deviation 26.258
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 11
|
12.38 units on a scale
Standard Deviation 19.944
|
15.28 units on a scale
Standard Deviation 24.035
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 12
|
10.48 units on a scale
Standard Deviation 21.038
|
9.09 units on a scale
Standard Deviation 23.417
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 13
|
7.84 units on a scale
Standard Deviation 20.199
|
7.94 units on a scale
Standard Deviation 17.965
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 14
|
12.90 units on a scale
Standard Deviation 23.847
|
7.02 units on a scale
Standard Deviation 13.962
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 15
|
9.20 units on a scale
Standard Deviation 21.633
|
9.80 units on a scale
Standard Deviation 19.596
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 16
|
16.05 units on a scale
Standard Deviation 28.300
|
10.42 units on a scale
Standard Deviation 23.472
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 17
|
12.12 units on a scale
Standard Deviation 26.318
|
8.89 units on a scale
Standard Deviation 15.258
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 18
|
15.69 units on a scale
Standard Deviation 31.441
|
7.14 units on a scale
Standard Deviation 14.194
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 19
|
11.11 units on a scale
Standard Deviation 25.950
|
2.38 units on a scale
Standard Deviation 8.909
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 20
|
9.09 units on a scale
Standard Deviation 30.151
|
8.33 units on a scale
Standard Deviation 15.076
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 21
|
9.09 units on a scale
Standard Deviation 30.151
|
2.78 units on a scale
Standard Deviation 9.623
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 22
|
15.15 units on a scale
Standard Deviation 31.140
|
6.06 units on a scale
Standard Deviation 13.484
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 23
|
9.09 units on a scale
Standard Deviation 21.556
|
6.67 units on a scale
Standard Deviation 14.055
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 24
|
16.67 units on a scale
Standard Deviation 36.004
|
3.33 units on a scale
Standard Deviation 10.541
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 25
|
16.67 units on a scale
Standard Deviation 36.004
|
8.33 units on a scale
Standard Deviation 15.430
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 26
|
23.81 units on a scale
Standard Deviation 41.786
|
4.76 units on a scale
Standard Deviation 12.599
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 27
|
22.22 units on a scale
Standard Deviation 40.369
|
4.17 units on a scale
Standard Deviation 11.785
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 28
|
22.22 units on a scale
Standard Deviation 40.369
|
12.50 units on a scale
Standard Deviation 17.252
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 29
|
11.11 units on a scale
Standard Deviation 27.217
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 30
|
0.00 units on a scale
Standard Deviation 0.000
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 31
|
0.00 units on a scale
Standard Deviation 0.000
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 32
|
0.00 units on a scale
Standard Deviation 0.000
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 33
|
0.00 units on a scale
Standard Deviation 0.000
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 34
|
22.22 units on a scale
Standard Deviation 38.490
|
5.56 units on a scale
Standard Deviation 13.608
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 35
|
16.67 units on a scale
Standard Deviation 23.570
|
11.11 units on a scale
Standard Deviation 17.213
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 36
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 37
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
8.33 units on a scale
Standard Deviation 16.667
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 39
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
22.22 units on a scale
Standard Deviation 38.490
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 41
|
—
|
11.11 units on a scale
Standard Deviation 19.245
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 42
|
—
|
0.00 units on a scale
Standard Deviation 0.000
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: Cycle 43
|
—
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
Body Image: EOT
|
23.23 units on a scale
Standard Deviation 32.792
|
18.39 units on a scale
Standard Deviation 31.605
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to maximum duration of 1226 days)Population: sKIT analysis set: enrolled participants who received at least 1 dose of study drug, had at least 1 biomarker parameter from corresponding assay sample with both baseline and post-treatment assessment. Here, "0 participants" in "number analyzed" field=none of the participants were evaluable in given group at this time point, hence data not reported
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=58 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle7/Day1
|
18222.9 picogram per milliliter (pcg/mL)
Standard Deviation 8010.89
|
19786.4 picogram per milliliter (pcg/mL)
Standard Deviation 10564.09
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle9/Day1
|
17677.0 picogram per milliliter (pcg/mL)
Standard Deviation 6179.43
|
19761.3 picogram per milliliter (pcg/mL)
Standard Deviation 12429.49
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle11/Day1
|
16689.8 picogram per milliliter (pcg/mL)
Standard Deviation 7452.02
|
21091.1 picogram per milliliter (pcg/mL)
Standard Deviation 13222.55
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle1/Day1
|
58218.8 picogram per milliliter (pcg/mL)
Standard Deviation 18406.35
|
62267.7 picogram per milliliter (pcg/mL)
Standard Deviation 17298.53
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle1/Day15
|
51614.2 picogram per milliliter (pcg/mL)
Standard Deviation 18638.21
|
48946.4 picogram per milliliter (pcg/mL)
Standard Deviation 15189.15
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle2/Day1
|
37705.1 picogram per milliliter (pcg/mL)
Standard Deviation 14128.27
|
40334.8 picogram per milliliter (pcg/mL)
Standard Deviation 14304.02
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle3/Day1
|
26939.9 picogram per milliliter (pcg/mL)
Standard Deviation 10839.77
|
30224.0 picogram per milliliter (pcg/mL)
Standard Deviation 13709.28
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle5/Day1
|
20596.1 picogram per milliliter (pcg/mL)
Standard Deviation 7331.69
|
23892.6 picogram per milliliter (pcg/mL)
Standard Deviation 11355.85
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle13/Day1
|
16657.7 picogram per milliliter (pcg/mL)
Standard Deviation 8876.97
|
18103.0 picogram per milliliter (pcg/mL)
Standard Deviation 7763.15
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle15/Day1
|
15675.0 picogram per milliliter (pcg/mL)
Standard Deviation 6591.98
|
16222.5 picogram per milliliter (pcg/mL)
Standard Deviation 4939.29
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle17/Day1
|
15705.5 picogram per milliliter (pcg/mL)
Standard Deviation 5665.32
|
15769.0 picogram per milliliter (pcg/mL)
Standard Deviation 7628.43
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle19/Day1
|
14600.0 picogram per milliliter (pcg/mL)
Standard Deviation 4537.41
|
15811.2 picogram per milliliter (pcg/mL)
Standard Deviation 7297.71
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle21/Day1
|
14809.5 picogram per milliliter (pcg/mL)
Standard Deviation 4395.74
|
15577.0 picogram per milliliter (pcg/mL)
Standard Deviation 5782.28
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle23/Day1
|
13332.3 picogram per milliliter (pcg/mL)
Standard Deviation 3670.43
|
12238.8 picogram per milliliter (pcg/mL)
Standard Deviation 4252.01
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle25/Day1
|
13674.0 picogram per milliliter (pcg/mL)
Standard Deviation 5440.63
|
13112.1 picogram per milliliter (pcg/mL)
Standard Deviation 5057.35
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle27/Day1
|
12616.0 picogram per milliliter (pcg/mL)
Standard Deviation 3513.31
|
16553.1 picogram per milliliter (pcg/mL)
Standard Deviation 8092.47
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle29/Day1
|
13638.8 picogram per milliliter (pcg/mL)
Standard Deviation 3555.38
|
16261.4 picogram per milliliter (pcg/mL)
Standard Deviation 10057.56
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle31/Day1
|
9567.5 picogram per milliliter (pcg/mL)
Standard Deviation 1644.02
|
10950.8 picogram per milliliter (pcg/mL)
Standard Deviation 4149.34
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle33/Day1
|
9440.0 picogram per milliliter (pcg/mL)
Standard Deviation 1541.49
|
10590.0 picogram per milliliter (pcg/mL)
Standard Deviation 4008.65
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle35/Day1
|
11255.0 picogram per milliliter (pcg/mL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
10241.7 picogram per milliliter (pcg/mL)
Standard Deviation 2748.91
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle37/Day1
|
—
|
9038.8 picogram per milliliter (pcg/mL)
Standard Deviation 3243.45
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle39/Day1
|
—
|
8672.5 picogram per milliliter (pcg/mL)
Standard Deviation 477.30
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle41/Day1
|
—
|
7023.3 picogram per milliliter (pcg/mL)
Standard Deviation 1849.00
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Cycle43/Day1
|
—
|
9360.0 picogram per milliliter (pcg/mL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Plasma Concentration of Soluble Protein Biomarker (sKIT)
EOT
|
21680.3 picogram per milliliter (pcg/mL)
Standard Deviation 10358.35
|
22605.5 picogram per milliliter (pcg/mL)
Standard Deviation 10953.00
|
SECONDARY outcome
Timeframe: Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5Population: Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters.
Ctrough is the minimum observed plasma concentration of drug. SU012662 is the metabolite of sunitinib.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle5/Day1
|
35.57 nanogram per milliliter (ng/mL)
Standard Deviation 15.221
|
33.60 nanogram per milliliter (ng/mL)
Standard Deviation 15.010
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
SU012662: Cycle1/Day15
|
18.03 nanogram per milliliter (ng/mL)
Standard Deviation 11.169
|
14.26 nanogram per milliliter (ng/mL)
Standard Deviation 9.264
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
SU012662: Cycle2/Day1
|
15.94 nanogram per milliliter (ng/mL)
Standard Deviation 9.059
|
12.53 nanogram per milliliter (ng/mL)
Standard Deviation 8.000
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
SU012662: Cycle3/Day1
|
15.85 nanogram per milliliter (ng/mL)
Standard Deviation 9.444
|
13.64 nanogram per milliliter (ng/mL)
Standard Deviation 6.983
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
SU012662: Cycle5/Day1
|
12.78 nanogram per milliliter (ng/mL)
Standard Deviation 6.375
|
12.61 nanogram per milliliter (ng/mL)
Standard Deviation 6.735
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle1/Day15
|
52.78 nanogram per milliliter (ng/mL)
Standard Deviation 27.361
|
41.93 nanogram per milliliter (ng/mL)
Standard Deviation 21.707
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle2/Day1
|
42.68 nanogram per milliliter (ng/mL)
Standard Deviation 20.320
|
38.38 nanogram per milliliter (ng/mL)
Standard Deviation 22.765
|
|
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle3/Day1
|
41.79 nanogram per milliliter (ng/mL)
Standard Deviation 21.517
|
38.49 nanogram per milliliter (ng/mL)
Standard Deviation 18.750
|
SECONDARY outcome
Timeframe: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5Population: PK population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters.
Dose-corrected plasma trough concentration is calculated as: trough plasma concentration\*(intended dose divided by actual dose). Intended dose was defined as the starting dose in the study and actual dose was defined as the last dose which the participant had received. SU012662 is the metabolite of sunitinib.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle1/Day15
|
52.66 ng/mL
Standard Deviation 27.136
|
43.38 ng/mL
Standard Deviation 21.520
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle2/Day1
|
42.89 ng/mL
Standard Deviation 20.607
|
39.52 ng/mL
Standard Deviation 19.833
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle3/Day1
|
44.99 ng/mL
Standard Deviation 23.031
|
38.56 ng/mL
Standard Deviation 18.375
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
Sunitinib: Cycle5/Day1
|
42.49 ng/mL
Standard Deviation 16.769
|
33.27 ng/mL
Standard Deviation 16.733
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
SU012662: Cycle1/Day15
|
18.14 ng/mL
Standard Deviation 11.059
|
14.79 ng/mL
Standard Deviation 9.436
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
SU012662: Cycle2/Day1
|
16.01 ng/mL
Standard Deviation 9.132
|
13.09 ng/mL
Standard Deviation 7.684
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
SU012662: Cycle3/Day1
|
17.37 ng/mL
Standard Deviation 10.233
|
14.22 ng/mL
Standard Deviation 7.085
|
|
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
SU012662: Cycle5/Day1
|
15.35 ng/mL
Standard Deviation 6.882
|
12.53 ng/mL
Standard Deviation 6.914
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)Population: Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.
Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitinib.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)Population: Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)Population: Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.
Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
59 Participants
|
45 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
57 Participants
|
44 Participants
|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) According to Severity
Grade 5
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Severity
Grade 1
|
4 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Severity
Grade 2
|
9 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Severity
Grade 3
|
38 Participants
|
23 Participants
|
|
Number of Participants With Adverse Events (AEs) According to Severity
Grade 4
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein), miscellaneous (pregnancy test, Chromogranin A). Clinically significant laboratory abnormalities were identified by the Investigator.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
30 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, body temperature and heart rate.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Change From Baseline in Vital Signs Abnormalities
|
30 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Change From Baseline in Physical Examinations Findings
|
23 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1939 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Participants with increase of \>=5 percent and decrease of \>=5 percent from baseline in body weight were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Change From Baseline in Body Weight
Increase of >=5 percent
|
27 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Body Weight
Decrease of >=5 percent
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here, "0 participants" in the "number analyzed" field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.
ECOG-PS performance status is used to assess how the disease affects the daily living abilities of the participant. It was measured on 6-point scale ranging from 0-5, where 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2= ambulatory for more than 50 percent of waking hours and capable of all self-care but unable to carry out any work activities; 3= capable of limited self-care, confined to bed or chair \>50 percent of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. A higher score indicated greater functional impairment. Only those ECOG-PS categories, in which at least one participant had data at any indicated time point were reported in this outcome measure. Not reported (NR) category included participants with unavailable ECOG performance status.
Outcome measures
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 Participants
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 Participants
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 1/Day 1: ECOG-PS =1
|
15 participants
|
14 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 1/Day 1: ECOG-PS =NR
|
9 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 2/Day 1: ECOG-PS =0
|
37 participants
|
30 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 2/Day 1: ECOG-PS =1
|
19 participants
|
13 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 3/Day 1: ECOG-PS =0
|
37 participants
|
29 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 3/Day 1: ECOG-PS =1
|
17 participants
|
10 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 3/Day 1: ECOG-PS =2
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 4/Day 1: ECOG-PS =0
|
34 participants
|
25 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 4/Day 1: ECOG-PS =1
|
15 participants
|
13 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 4/Day 1: ECOG-PS =NR
|
2 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 5/Day 1: ECOG-PS =1
|
13 participants
|
11 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 6/Day 1: ECOG-PS =0
|
30 participants
|
21 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 6/Day 1: ECOG-PS =1
|
13 participants
|
9 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 7/Day 1: ECOG-PS =0
|
27 participants
|
21 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 9/Day 1: ECOG-PS =0
|
24 participants
|
20 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 10/Day 1: ECOG-PS =0
|
22 participants
|
18 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 10/Day 1: ECOG-PS =1
|
13 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 10/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 13/Day 1: ECOG-PS =0
|
21 participants
|
15 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 13/Day 1: ECOG-PS =1
|
13 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 14/Day 1: ECOG-PS =1
|
11 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 16/Day 1: ECOG-PS =1
|
10 participants
|
3 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 16/Day 1: ECOG-PS =NR
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 17/Day 1: ECOG-PS =0
|
15 participants
|
13 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 17/Day 1: ECOG-PS =1
|
6 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 17/Day 1: ECOG-PS =NR
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 18/Day 1: ECOG-PS =0
|
10 participants
|
12 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 18/Day 1: ECOG-PS =1
|
5 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 18/Day 1: ECOG-PS =NR
|
2 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 19/Day 1: ECOG-PS =0
|
8 participants
|
12 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 19/Day 1: ECOG-PS =1
|
3 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 19/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 19/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 20/Day 1: ECOG-PS =0
|
8 participants
|
11 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 20/Day 1: ECOG-PS =1
|
2 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 20/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 20/Day 1: ECOG-PS =NR
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 21/Day 1: ECOG-PS =0
|
7 participants
|
9 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 21/Day 1: ECOG-PS =1
|
4 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 21/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 22/Day 1: ECOG-PS =0
|
8 participants
|
8 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 22/Day 1: ECOG-PS =1
|
3 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 22/Day 1: ECOG-PS =3
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 22/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 23/Day 1: ECOG-PS =0
|
8 participants
|
7 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 23/Day 1: ECOG-PS =1
|
2 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 23/Day 1: ECOG-PS =NR
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 24/Day 1: ECOG-PS =0
|
9 participants
|
7 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 24/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 25/Day 1: ECOG-PS =0
|
8 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 25/Day 1: ECOG-PS =1
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 25/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 25/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 26/Day 1: ECOG-PS =0
|
5 participants
|
7 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 26/Day 1: ECOG-PS =1
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 26/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 27/Day 1: ECOG-PS =0
|
4 participants
|
7 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 27/Day 1: ECOG-PS =1
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 27/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 27/Day 1: ECOG-PS =NR
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 28/Day 1: ECOG-PS =0
|
5 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 28/Day 1: ECOG-PS =1
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 28/Day 1: ECOG-PS =2
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 28/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 29/Day 1: ECOG-PS =0
|
5 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 29/Day 1: ECOG-PS =1
|
1 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 29/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 30/Day 1: ECOG-PS =0
|
5 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 30/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 31/Day 1: ECOG-PS =0
|
2 participants
|
5 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 31/Day 1: ECOG-PS =1
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 31/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 32/Day 1: ECOG-PS =0
|
3 participants
|
5 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 32/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 33/Day 1: ECOG-PS =0
|
2 participants
|
4 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 33/Day 1: ECOG-PS =1
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 33/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 34/Day 1: ECOG-PS =0
|
3 participants
|
4 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 34/Day 1: ECOG-PS =1
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 34/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 35/Day 1: ECOG-PS =0
|
2 participants
|
4 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 35/Day 1: ECOG-PS =1
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 35/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 36/Day 1: ECOG-PS =0
|
1 participants
|
3 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 36/Day 1: ECOG-PS =1
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 36/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 37/Day 1: ECOG-PS =0
|
1 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 37/Day 1: ECOG-PS =1
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 37/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 38/Day 1: ECOG-PS =0
|
1 participants
|
3 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 38/Day 1: ECOG-PS =1
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 39/Day 1: ECOG-PS =0
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 39/Day 1: ECOG-PS =1
|
0 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 41/Day 1: ECOG-PS =0
|
—
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 41/Day 1: ECOG-PS =1
|
—
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 41/Day 1: ECOG-PS =NR
|
—
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 42/Day 1: ECOG-PS =1
|
—
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 43/Day 1: ECOG-PS =1
|
—
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
EOT: ECOG-PS =0
|
20 participants
|
14 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
EOT: ECOG-PS =1
|
13 participants
|
12 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
EOT: ECOG-PS =2
|
0 participants
|
4 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
EOT: ECOG-PS =3
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 5/Day 1: ECOG-PS =2
|
1 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 6/Day 1: ECOG-PS =2
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 40/Day 1: ECOG-PS =0
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 7/Day 1: ECOG-PS =1
|
13 participants
|
7 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 40/Day 1: ECOG-PS =1
|
1 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 7/Day 1: ECOG-PS =2
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 8/Day 1: ECOG-PS =0
|
24 participants
|
20 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
EOT: ECOG-PS =NR
|
9 participants
|
7 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 8/Day 1: ECOG-PS =1
|
13 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 9/Day 1: ECOG-PS =1
|
11 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 11/Day 1: ECOG-PS =0
|
22 participants
|
18 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 11/Day 1: ECOG-PS =1
|
13 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 12/Day 1: ECOG-PS =0
|
22 participants
|
16 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 12/Day 1: ECOG-PS =1
|
13 participants
|
6 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 14/Day 1: ECOG-PS =0
|
19 participants
|
12 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 14/Day 1: ECOG-PS =NR
|
1 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 15/Day 1: ECOG-PS =0
|
20 participants
|
13 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 15/Day 1: ECOG-PS =1
|
10 participants
|
4 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 16/Day 1: ECOG-PS =0
|
16 participants
|
13 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 2/Day 1: ECOG-PS =NR
|
3 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 1/Day 1: ECOG-PS =0
|
37 participants
|
25 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 3/Day 1: ECOG-PS =3
|
0 participants
|
1 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 3/Day 1: ECOG-PS =NR
|
2 participants
|
0 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 5/Day 1: ECOG-PS =0
|
34 participants
|
23 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 24/Day 1: ECOG-PS =1
|
0 participants
|
2 participants
|
|
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Cycle 24/Day 1: ECOG-PS =NR
|
0 participants
|
1 participants
|
Adverse Events
Sunitinib: Treatment Naive Cohort
Sunitinib: Later-Line Cohort
Serious adverse events
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 participants at risk
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 participants at risk
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Anal fistula
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver injury
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Arteriosclerosis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Sunitinib: Treatment Naive Cohort
n=61 participants at risk
Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
|
Sunitinib: Later-Line Cohort
n=45 participants at risk
Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
|
|---|---|---|
|
Hepatobiliary disorders
Ocular icterus
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Amnesia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysaesthesia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
23.0%
14/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
24.4%
11/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.0%
11/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
9/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
42.6%
26/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
46.7%
21/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.7%
37/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
51.1%
23/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
29.5%
18/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
33.3%
15/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
19.7%
12/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
9/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiovascular symptom
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Goitre
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye haemorrhage
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid bleeding
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid oedema
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Keratitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Lacrimation increased
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Periorbital oedema
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal vascular disorder
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.6%
15/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
9/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
6/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Anal inflammation
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.1%
33/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
48.9%
22/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.1%
8/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
31.1%
14/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.9%
4/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival swelling
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Glossodynia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
5/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
23.0%
14/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
31.1%
14/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Proctitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Regurgitation
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
24.6%
15/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
6/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
8/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
22.2%
10/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
18.0%
11/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Discomfort
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Face oedema
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Facial pain
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
32.8%
20/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
28.9%
13/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling cold
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
9.8%
6/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
5/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucous membrane disorder
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
9.8%
6/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
17.8%
8/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholangitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Jaundice
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver injury
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypogeusia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Enterocolitis infectious
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Furuncle
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gingival abscess
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gingivitis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
6/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Paronychia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
6/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
17.8%
8/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood chloride decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood chromogranin A increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood folate decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood iron decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood phosphorus decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium decreased
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone abnormal
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood urine present
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Ejection fraction decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram T wave abnormal
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count decreased
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Occult blood positive
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count decreased
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein urine
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein urine present
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cell count decreased
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cells urine positive
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Thyroxine free decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Tri-iodothyronine decreased
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Tri-iodothyronine free decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Urinary sediment present
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Urobilinogen urine increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Vitamin B12 decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
18.0%
11/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
9.8%
6/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cells urine positive
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.5%
7/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
6/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.5%
7/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.9%
4/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.9%
4/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
6/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
7/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Polyneuropathy
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.6%
7/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal disorder
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Genital erythema
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Penile erythema
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
6/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.9%
4/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.5%
7/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
5/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
5/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.5%
7/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
4/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.9%
4/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
6/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Macule
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
4.9%
3/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
31.1%
19/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
31.1%
14/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
8.2%
5/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
7/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
3/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
13.1%
8/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.4%
2/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Flushing
|
3.3%
2/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haemorrhage
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
26.2%
16/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
28.9%
13/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium increased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood albumin decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Glucose urine present
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Glutathione s-transferase increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Procalcitonin increased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Protein total decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Thyroid hormones decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Total bile acids increased
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal impairment
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Tooth extraction
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Chillblains
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hypoalbuminaemia
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
2.2%
1/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Bilirubin conjugated increased
|
1.6%
1/61 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/45 • Baseline up to 1939 days
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 participant and as nonserious in another participant, or one participant 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