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Clinical Trial Results:
A Single-arm Open-label International Multi-center Study Of The Efficacy And Safety Of Sunitinib Malate (SU011248, Sutent (Registered)) In Patients With Progressive Advanced Metastatic Well-differentiated Unresectable Pancreatic Neuroendocrine Tumors

Summary
EudraCT number	2011-004363-74
Trial protocol	CZ NL HU ES BE PT PL SK EE IT
Global end of trial date	26 Jul 2018

Results information
Results version number	v2(current)
This version publication date	31 Jul 2019
First version publication date	26 Mar 2017
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

A6181202

ISRCTN number

US NCT number

NCT01525550

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

13 Dec 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

26 Jul 2018

Was the trial ended prematurely?

Main objective of the trial

To confirm sunitinib treatment effect on progression-free survival (PFS) per investigator assessment in subjects with advanced/metastatic, well-differentiated, unresectable, pancreatic neuroendocrine tumors per Response Evaluation Criteria in Solid Tumors (RECIST 1.0).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

06 Jun 2012

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy, Safety

Long term follow-up duration

3 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 4

Country: Number of subjects enrolled

Belgium: 3

Country: Number of subjects enrolled

China: 31

Country: Number of subjects enrolled

Czech Republic: 10

Country: Number of subjects enrolled

France: 2

Country: Number of subjects enrolled

Hungary: 5

Country: Number of subjects enrolled

India: 2

Country: Number of subjects enrolled

Italy: 12

Country: Number of subjects enrolled

Japan: 4

Country: Number of subjects enrolled

Norway: 6

Country: Number of subjects enrolled

Romania: 12

Country: Number of subjects enrolled

Slovakia: 1

Country: Number of subjects enrolled

South Africa: 3

Country: Number of subjects enrolled

Spain: 7

Country: Number of subjects enrolled

United States: 4

Worldwide total number of subjects

106

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

The study was conducted for a total of 106 subjects between 6 June 2012 and 26 July 2018. "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.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Sunitinib: Treatment Naive Cohort

Arm description

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 subjects.

Arm type

Experimental

Investigational medicinal product name

Sunitinib 37.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects received Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle.

Sunitinib: Later-Line Cohort

Arm description

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 (subjects who developed progressive disease on or after prior systemic therapy).

Arm type

Experimental

Investigational medicinal product name

Sunitinib 37.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects received Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle.

Number of subjects in period 1	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Started	61	45
Completed	0	0
Not completed	61	45
Consent withdrawn by subject	4	-
Death	19	28
Sponsor Decision	30	11
Unspecified	-	4
Lost to follow-up	8	2

Baseline characteristics

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Reporting group title

Sunitinib: Treatment Naive Cohort

Reporting group description

Reporting group title

Sunitinib: Later-Line Cohort

Reporting group description

Reporting group values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort	Total
Number of subjects	61	45	106
Age categorical
Units: Subjects
18-64 years	53	39	92
65-84 years	8	6	14
Age Continuous
Units: years
arithmetic mean (standard deviation)	55.4 ( 8.9 )	53.5 ( 9.1 )	-
Gender, Male/Female
Units: Subjects
Female	31	12	43
Male	30	33	63

End points

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Reporting group title

Sunitinib: Treatment Naive Cohort

Reporting group description

Reporting group title

Sunitinib: Later-Line Cohort

Reporting group description

Primary: Progression-Free Survival (PFS): Investigator Assessment

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End point title

Progression-Free Survival (PFS): Investigator Assessment ^[1]

End point description

Investigator assessed PFS was defined as time (in months) from date of enrollment in study to 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 subject was censored at date of subject’s last progression-free tumor assessment prior to study cut-off date. Progression as per 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 smallest sum of the LD recorded since treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. FAS included all subjects who were enrolled into study regardless of whether subjects received study drug or not.

End point type

Primary

End point timeframe

Baseline until disease progression or death due to any cause (up to 1226 days)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive statistics were planned for this endpoint

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: months
median (confidence interval 95%)	13.2 (7.4 to 16.8)	13.0 (9.2 to 20.4)

No statistical analyses for this end point

Secondary: Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment

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End point title

Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment

End point description

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 subject was censored at the date of the subject’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. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.

End point type

Secondary

End point timeframe

Baseline until disease progression or death due to any cause (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: months
median (confidence interval 95%)	11.1 (5.5 to 16.7)	9.5 (7.4 to 18.4)

No statistical analyses for this end point

Secondary: Time to Tumor Progression (TTP): Investigator Assessment

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End point title

Time to Tumor Progression (TTP): Investigator Assessment

End point description

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. FAS included all subjects who were enrolled into the study regardless of whether they received study drug or not.

End point type

Secondary

End point timeframe

Baseline until first documented tumor progression (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: months
median (confidence interval 95%)	14.8 (7.5 to 16.8)	14.5 (9.2 to 20.4)

No statistical analyses for this end point

Secondary: Overall Survival (OS)

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End point title

Overall Survival (OS)

End point description

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 subject was censored at the earliest of the last date the subject was known to be alive or the study cut-off date. Here, "99999" for median and confidence interval (CI) signifies data not available (NA) due to the less number of participants who had event. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.

End point type

Secondary

End point timeframe

Baseline until death or study cut-off (up to 1939 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: Months
median (confidence interval 95%)	99999 (41.7 to 99999)	37.9 (22.9 to 56.1)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Objective Response (OR): Investigator Assessment

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End point title

Percentage of Subjects With Objective Response (OR): Investigator Assessment

End point description

Investigator assessed OR in subjects 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 subjects with investigator assessed OR were reported. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.

End point type

Secondary

End point timeframe

Baseline until disease progression or death due to any cause (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: percentage of subjects
number (confidence interval 95%)	21.3 (11.9 to 33.7)	28.9 (16.4 to 44.3)

No statistical analyses for this end point

Secondary: Duration of Response (DOR): Investigator Assessment

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End point title

Duration of Response (DOR): Investigator Assessment

End point description

Investigator assessed DOR was defined as time (in months) from date of first documented objective tumor response (CR or PR) that was subsequently confirmed to first documented objective tumor progression or death due to any cause, whichever occurred first according to RECIST 1.0 and sustained for at least 4 weeks, confirmed by repeat tumor assessments. CR: disappearance of all target and non-target lesions. PR: >=30 percent decrease in 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 appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. Here, "99999" for CI signifies data not available (NA) due to the less number of subjects who had event. Subset of FAS which included all subjects who had response.

End point type

Secondary

End point timeframe

Baseline until disease progression or death due to any cause (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	13	13
Units: months
median (confidence interval 95%)	19.1 (10.1 to 99999)	14.7 (5.5 to 21.9)

No statistical analyses for this end point

Secondary: Time to Tumor Response (TTR): Investigator Assessment

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End point title

Time to Tumor Response (TTR): Investigator Assessment

End point description

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. Subset of FAS which included all subjects who had response.

End point type

Secondary

End point timeframe

Baseline until first documented objective tumor response (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	13	13
Units: months
median (full range (min-max))	3.8 (1.0 to 11.1)	3.8 (1.0 to 9.3)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Objective Response: Independent Radiological Review (IRR) Assessment

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End point title

Percentage of Subjects With Objective Response: Independent Radiological Review (IRR) Assessment

End point description

IRR assessed OR in subjects 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 subjects with objective response were reported in this endpoint. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.

End point type

Secondary

End point timeframe

Baseline until disease progression or death due to any cause (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: percentage of subjects
number (confidence interval 95%)	52.5 (39.3 to 65.4)	55.6 (40.0 to 70.4)

No statistical analyses for this end point

Secondary: Duration of Response (DOR): Independent Radiological Review (IRR) Assessment

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End point title

Duration of Response (DOR): Independent Radiological Review (IRR) Assessment

End point description

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. Here, "99999" for median and CI signifies data not available (NA) due to the small number of subjects who encountered tumor progression or death. Subset of FAS which included all subjects who had response.

End point type

Secondary

End point timeframe

Baseline until disease progression or death due to any cause (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	32	25
Units: months
number (confidence interval 95%)	99999 (17.8 to 99999)	19.2 (15.7 to 35.9)

No statistical analyses for this end point

Secondary: Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment

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End point title

Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment

End point description

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. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. 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. Subset of FAS which included all subjects who had response.

End point type

Secondary

End point timeframe

Baseline until first documented objective tumor response (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	32	25
Units: months
median (full range (min-max))	1.0 (0.8 to 7.3)	1.0 (0.9 to 3.7)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Chromogranin A (CgA) Response

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End point title

Percentage of Subjects With Chromogranin A (CgA) Response

End point description

CgA response in subjects 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 subjects with CgA response were reported. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.

End point type

Secondary

End point timeframe

Baseline until CgA response or death due to any cause (up to 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: percentage of subjects
number (confidence interval 95%)	16.4 (9.6 to 32.5)	11.1 (4.0 to 25.6)

No statistical analyses for this end point

Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

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End point title

Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

End point description

EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess subject quality of life (QOL).First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, vomiting, pain)and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Questions assessed on 4-point scale(1=not at all, 2=a little, 3=quite a bit, 4=very much), high score=high level of problem.Last 2 questions used for evaluating global health status/QOL. 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. Here, "99999" for mean and standard deviation signifies data not available (NA) as none of subjects were evaluable in given group at this time point. FAS population and 'n' signifies those subjects who were evaluable at specified time point for each arm.

End point type

Secondary

End point 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)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: units on a scale
arithmetic mean (standard deviation)
Global health status:Cycle 1 (n=61,43)	71.31 ( 21.111 )	66.09 ( 20.282 )
Global health status: Cycle 2 (n=56,41)	69.94 ( 19.311 )	65.45 ( 20.880 )
Global health status: Cycle 3 (n=55,40)	70.30 ( 21.502 )	60.83 ( 26.768 )
Global health status: Cycle 4 (n=50,38)	70.00 ( 21.429 )	61.84 ( 25.010 )
Global health status: Cycle 5 (n=47,34)	69.15 ( 19.421 )	65.93 ( 24.306 )
Global health status: Cycle 6 (n=43,31)	68.41 ( 18.053 )	65.32 ( 20.310 )
Global health status: Cycle 7 (n=39,29)	68.38 ( 21.132 )	61.21 ( 24.016 )
Global health status: Cycle 8 (n=37,25)	70.05 ( 17.062 )	65.33 ( 20.649 )
Global health status: Cycle 9 (n=35,26)	66.90 ( 20.058 )	65.71 ( 20.045 )
Global health status: Cycle 10 (n=35,23)	68.10 ( 20.561 )	63.04 ( 18.434 )
Global health status: Cycle 11 (n=35,24)	63.81 ( 21.384 )	66.67 ( 19.812 )
Global health status: Cycle 12 (n=35,22)	65.71 ( 22.395 )	64.77 ( 22.848 )
Global health status: Cycle 13 (n=34,21)	67.89 ( 20.733 )	66.67 ( 19.365 )
Global health status: Cycle 14 (n=31,19)	68.28 ( 20.797 )	57.89 ( 18.937 )
Global health status: Cycle 15 (n=30,17)	66.67 ( 22.318 )	64.71 ( 21.757 )
Global health status: Cycle 16 (n=27,16)	64.51 ( 21.005 )	67.19 ( 17.339 )
Global health status: Cycle 17 (n=22,15)	62.50 ( 23.110 )	67.78 ( 15.706 )
Global health status: Cycle 18 (n=17,14)	58.33 ( 24.826 )	70.83 ( 18.125 )
Global health status: Cycle 19 (n=12,14)	54.86 ( 24.736 )	66.67 ( 20.672 )
Global health status: Cycle 20 (n=11,13)	55.30 ( 25.893 )	64.74 ( 17.398 )
Global health status: Cycle 21 (n=11,12)	55.30 ( 23.650 )	65.28 ( 18.407 )
Global health status: Cycle 22 (n=11,11)	56.06 ( 23.889 )	62.88 ( 27.224 )
Global health status: Cycle 23 (n=11,10)	56.82 ( 24.386 )	59.17 ( 20.953 )
Global health status: Cycle 24 (n=10,10)	50.00 ( 23.570 )	60.83 ( 19.265 )
Global health status: Cycle 25 (n=10,8)	51.67 ( 19.954 )	61.46 ( 16.022 )
Global health status: Cycle 26 (n=7,7)	50.00 ( 20.972 )	65.48 ( 13.968 )
Global health status: Cycle 27 (n=6,8)	41.67 ( 12.910 )	61.46 ( 17.216 )
Global health status: Cycle 28 (n=7,8)	44.05 ( 20.813 )	61.46 ( 16.022 )
Global health status: Cycle 29 (n=5,7)	56.67 ( 19.003 )	63.10 ( 16.567 )
Global health status: Cycle 30 (n=4,7)	52.08 ( 21.916 )	64.29 ( 14.996 )
Global health status: Cycle 31 (n=2,7)	58.33 ( 11.785 )	60.71 ( 20.813 )
Global health status: Cycle 32 (n=3,6)	61.11 ( 19.245 )	59.72 ( 15.290 )
Global health status: Cycle 33 (n=3,6)	61.11 ( 12.729 )	55.56 ( 22.771 )
Global health status: Cycle 34 (n=3,6)	58.33 ( 25.000 )	55.56 ( 20.861 )
Global health status: Cycle 35 (n=2,6)	66.67 ( 23.570 )	61.11 ( 13.608 )
Global health status: Cycle 36 (n=1,5)	83.33 ( 99999 )	58.33 ( 16.667 )
Global health status: Cycle 37 (n=1,4)	83.33 ( 99999 )	58.33 ( 21.517 )
Global health status: Cycle 38 (n=0,4)	99999 ( 99999 )	58.33 ( 21.517 )
Global health status: Cycle 39 (n=1,3)	83.33 ( 99999 )	50.00 ( 16.667 )
Global health status: Cycle 40 (n=1,3)	83.33 ( 99999 )	50.00 ( 16.667 )
Global health status: Cycle 41 (n=0,3)	99999 ( 99999 )	50.00 ( 16.667 )
Global health status: Cycle 42 (n=0,2)	99999 ( 99999 )	45.83 ( 5.893 )
Global health status: Cycle 43 (n=0,1)	99999 ( 99999 )	50.00 ( 99999 )
Global health status: EOT (n=33,30)	60.10 ( 22.318 )	50.00 ( 22.210 )
Physical Functioning: Cycle 1 (n=61,44)	90.38 ( 14.733 )	86.93 ( 12.677 )
Physical Functioning: Cycle 2 (n=57,42)	89.71 ( 10.988 )	86.51 ( 13.929 )
Physical Functioning: Cycle 3 (n=55,40)	88.73 ( 12.886 )	85.00 ( 17.263 )
Physical Functioning: Cycle 4 (n=50,38)	89.07 ( 10.412 )	83.68 ( 16.958 )
Physical Functioning: Cycle 5 (n=47,34)	88.23 ( 11.311 )	87.06 ( 17.519 )
Physical Functioning: Cycle 6 (n=43,31)	87.91 ( 11.293 )	83.44 ( 18.924 )
Physical Functioning: Cycle 7 (n=39,29)	86.24 ( 12.891 )	84.14 ( 15.473 )
Physical Functioning: Cycle 8 (n=37,25)	85.23 ( 12.486 )	88.27 ( 11.102 )
Physical Functioning: Cycle 9 (n=35,26)	84.00 ( 13.255 )	87.18 ( 14.474 )
Physical Functioning: Cycle 10 (n=35,23)	86.67 ( 11.771 )	87.25 ( 15.943 )
Physical Functioning: Cycle 11 (n=35,24)	84.19 ( 12.944 )	90.83 ( 10.552 )
Physical Functioning: Cycle 12 (n=35,22)	84.38 ( 15.419 )	88.48 ( 11.489 )
Physical Functioning: Cycle 13 (n=34,21)	87.45 ( 11.808 )	89.52 ( 10.016 )
Physical Functioning: Cycle 14 (n=31,19)	86.67 ( 12.996 )	86.67 ( 10.423 )
Physical Functioning: Cycle 15 (n=30,17)	85.33 ( 11.534 )	89.02 ( 11.041 )
Physical Functioning: Cycle 16 (n=27,16)	83.70 ( 18.053 )	89.58 ( 10.319 )
Physical Functioning: Cycle 17 (n=22,15)	82.42 ( 16.657 )	88.00 ( 9.155 )
Physical Functioning: Cycle 18 (n=17,14)	82.35 ( 18.248 )	90.95 ( 8.516 )
Physical Functioning: Cycle 19 (n=12,14)	75.00 ( 22.406 )	89.52 ( 9.324 )
Physical Functioning: Cycle 20 (n=11,13)	74.55 ( 20.181 )	89.74 ( 8.439 )
Physical Functioning: Cycle 21 (n=11,12)	75.15 ( 17.911 )	90.00 ( 7.785 )
Physical Functioning: Cycle 22 (n=11,11)	77.58 ( 22.563 )	81.82 ( 24.782 )
Physical Functioning: Cycle 23 (n=11,10)	77.73 ( 18.170 )	82.67 ( 14.470 )
Physical Functioning: Cycle 24 (n=10,10)	72.67 ( 22.760 )	82.67 ( 14.807 )
Physical Functioning: Cycle 25 (n=10,8)	74.67 ( 23.685 )	89.17 ( 10.653 )
Physical Functioning: Cycle 26 (n=7,7)	66.67 ( 25.531 )	83.81 ( 13.801 )
Physical Functioning: Cycle 27 (n=6,8)	62.22 ( 27.217 )	85.83 ( 12.051 )
Physical Functioning: Cycle 28 (n=7,8)	69.52 ( 21.381 )	87.50 ( 11.513 )
Physical Functioning: Cycle 29 (n=6,7)	80.00 ( 10.328 )	83.81 ( 15.803 )
Physical Functioning: Cycle 30 (n=5,7)	84.00 ( 3.651 )	84.76 ( 11.362 )
Physical Functioning: Cycle 31 (n=3,7)	77.78 ( 10.184 )	85.71 ( 13.569 )
Physical Functioning: Cycle 32 (n=3,6)	84.44 ( 3.849 )	82.22 ( 10.037 )
Physical Functioning: Cycle 33 (n=3,6)	73.33 ( 6.667 )	83.33 ( 10.954 )
Physical Functioning: Cycle 34 (n=3,6)	64.44 ( 21.430 )	80.00 ( 12.649 )
Physical Functioning: Cycle 35 (n=2,6)	70.00 ( 23.570 )	78.89 ( 12.939 )
Physical Functioning: Cycle 36 (n=1,5)	86.67 ( 99999 )	80.00 ( 9.428 )
Physical Functioning: Cycle 37 (n=1,4)	86.67 ( 99999 )	76.67 ( 3.849 )
Physical Functioning: Cycle 38 (n=0,4)	99999 ( 99999 )	75.00 ( 6.383 )
Physical Functioning: Cycle 39 (n=1,3)	86.67 ( 99999 )	77.78 ( 3.849 )
Physical Functioning: Cycle 40 (n=1,3)	93.33 ( 99999 )	71.11 ( 10.184 )
Physical Functioning: Cycle 41 (n=0,3)	99999 ( 99999 )	77.78 ( 10.184 )
Physical Functioning: Cycle 42 (n=0,2)	99999 ( 99999 )	80.00 ( 0.000 )
Physical Functioning: Cycle 43 (n=0,1)	99999 ( 99999 )	80.00 ( 99999 )
Physical Functioning: EOT(n=33,30)	76.16 ( 23.454 )	78.00 ( 19.191 )
Role Functioning: Cycle 1 (n=60,44)	88.33 ( 20.424 )	85.61 ( 18.880 )
Role Functioning: Cycle 2 (n=57,42)	85.67 ( 17.089 )	80.56 ( 25.214 )
Role Functioning: Cycle 3 (n=55,40)	85.15 ( 18.613 )	80.83 ( 25.473 )
Role Functioning: Cycle 4 (n=50,38)	84.67 ( 17.444 )	80.26 ( 23.841 )
Role Functioning: Cycle 5 (n=47,34)	85.82 ( 19.343 )	82.35 ( 23.904 )
Role Functioning: Cycle 6 (n=43,31)	86.05 ( 16.639 )	79.57 ( 25.353 )
Role Functioning: Cycle 7 (n=39,29)	83.33 ( 21.965 )	81.03 ( 24.285 )
Role Functioning: Cycle 8 (n=37,25)	80.63 ( 19.049 )	85.33 ( 16.887 )
Role Functioning: Cycle 9 (n=35,26)	76.19 ( 22.968 )	80.77 ( 22.945 )
Role Functioning: Cycle 10 (n=35,23)	82.86 ( 18.737 )	83.33 ( 23.028 )
Role Functioning: Cycle 11 (n=35,24)	79.52 ( 22.537 )	86.11 ( 18.822 )
Role Functioning: Cycle 12 (n=35,22)	79.52 ( 20.246 )	84.85 ( 19.182 )
Role Functioning: Cycle 13 (n=34,21)	82.35 ( 19.219 )	84.13 ( 17.059 )
Role Functioning: Cycle 14 (n=31,19)	81.72 ( 20.346 )	79.82 ( 19.704 )
Role Functioning: Cycle 15 (n=30,17)	77.22 ( 22.946 )	77.45 ( 22.777 )
Role Functioning: Cycle 16 (n=27,16)	77.16 ( 24.956 )	84.38 ( 15.478 )
Role Functioning: Cycle 17 (n=22,15)	74.24 ( 24.520 )	82.22 ( 17.213 )
Role Functioning: Cycle 18 (n=17,14)	75.49 ( 28.332 )	84.52 ( 16.621 )
Role Functioning: Cycle 19 (n=12,14)	66.67 ( 26.591 )	79.76 ( 20.856 )
Role Functioning: Cycle 20 (n=11,13)	69.70 ( 27.707 )	80.77 ( 19.059 )
Role Functioning: Cycle 21 (n=11,12)	68.18 ( 27.340 )	79.17 ( 23.704 )
Role Functioning: Cycle 22 (n=11,11)	68.18 ( 29.302 )	71.21 ( 29.899 )
Role Functioning: Cycle 23 (n=11,10)	63.64 ( 30.567 )	71.67 ( 24.907 )
Role Functioning: Cycle 24 (n=10,10)	60.00 ( 27.442 )	76.67 ( 22.498 )
Role Functioning: Cycle 25 (n=10,8)	58.33 ( 30.682 )	77.08 ( 23.465 )
Role Functioning: Cycle 26 (n=7,7)	57.14 ( 30.211 )	83.33 ( 16.667 )
Role Functioning: Cycle 27 (n=6,8)	58.33 ( 36.132 )	77.08 ( 23.465 )
Role Functioning: Cycle 28 (n=7,8)	59.52 ( 18.898 )	79.17 ( 24.801 )
Role Functioning: Cycle 29 (n=6,7)	75.00 ( 13.944 )	78.57 ( 24.934 )
Role Functioning: Cycle 30 (n=5,7)	90.00 ( 14.907 )	76.19 ( 25.198 )
Role Functioning: Cycle 31 (n=3,7)	83.33 ( 16.667 )	78.57 ( 24.934 )
Role Functioning: Cycle 32 (n=3,6)	94.44 ( 9.623 )	77.78 ( 20.184 )
Role Functioning: Cycle 33 (n=3,6)	88.89 ( 19.245 )	72.22 ( 25.092 )
Role Functioning: Cycle 34 (n=3,6)	72.22 ( 34.694 )	69.44 ( 30.581 )
Role Functioning: Cycle 35 (n=2,6)	75.00 ( 35.355 )	72.22 ( 25.092 )
Role Functioning: Cycle 36 (n=1,5)	100.00 ( 99999 )	73.33 ( 19.003 )
Role Functioning: Cycle 37 (n=1,4)	66.67 ( 99999 )	70.83 ( 28.464 )
Role Functioning: Cycle 38 (n=0,4)	99999 ( 99999 )	66.67 ( 27.217 )
Role Functioning: Cycle 39 (n=1,3)	100.00 ( 99999 )	55.56 ( 19.245 )
Role Functioning: Cycle 40 (n=1,3)	100.00 ( 99999 )	55.56 ( 9.623 )
Role Functioning: Cycle 41 (n=0,3)	99999 ( 99999 )	55.56 ( 19.245 )
Role Functioning: Cycle 42 (n=0,2)	99999 ( 99999 )	66.67 ( 0.000 )
Role Functioning: Cycle 43 (n=0,1)	99999 ( 99999 )	66.67 ( 99999 )
Role Functioning: EOT (n=33,30)	70.71 ( 26.031 )	65.56 ( 36.075 )
Emotional Functioning: Cycle 1 (n=61,43)	80.19 ( 18.644 )	76.23 ( 18.238 )
Emotional Functioning: Cycle 2 (n=57,41)	84.31 ( 17.619 )	77.64 ( 17.021 )
Emotional Functioning: Cycle 3 (n=55,40)	82.53 ( 18.792 )	73.96 ( 24.401 )
Emotional Functioning: Cycle 4 (n=50,38)	82.67 ( 16.906 )	77.41 ( 22.167 )
Emotional Functioning: Cycle 5 (n=47,34)	82.09 ( 18.632 )	79.66 ( 21.141 )
Emotional Functioning: Cycle 6 (n=43,31)	82.17 ( 17.871 )	73.92 ( 24.696 )
Emotional Functioning: Cycle 7 (n=39,29)	80.56 ( 21.059 )	73.56 ( 26.075 )
Emotional Functioning: Cycle 8 (n=37,25)	80.63 ( 21.877 )	76.00 ( 18.991 )
Emotional Functioning: Cycle 9 (n=35,26)	80.24 ( 19.812 )	76.92 ( 18.304 )
Emotional Functioning: Cycle 10 (n=35,23)	81.27 ( 19.818 )	76.45 ( 21.998 )
Emotional Functioning: Cycle 11 (n=35,24)	79.76 ( 19.311 )	75.46 ( 20.587 )
Emotional Functioning: Cycle 12 (n=35,22)	78.10 ( 23.052 )	75.76 ( 22.700 )
Emotional Functioning: Cycle 13 (n=34,21)	77.45 ( 22.429 )	77.38 ( 19.211 )
Emotional Functioning: Cycle 14 (n=31,19)	78.49 ( 20.387 )	75.00 ( 24.375 )
Emotional Functioning: Cycle 15 (n=30,17)	80.00 ( 21.173 )	74.51 ( 23.839 )
Emotional Functioning: Cycle 16 (n=27,16)	82.10 ( 22.133 )	75.00 ( 24.343 )
Emotional Functioning: Cycle 17 (n=22,15)	79.92 ( 23.522 )	79.44 ( 19.382 )
Emotional Functioning: Cycle 18 (n=17,14)	78.92 ( 23.592 )	76.19 ( 25.499 )
Emotional Functioning: Cycle 19 (n=12,14)	73.61 ( 28.611 )	73.81 ( 25.288 )
Emotional Functioning: Cycle 20 (n=11,13)	71.21 ( 29.666 )	78.85 ( 25.823 )
Emotional Functioning: Cycle 21 (n=11,12)	76.52 ( 28.824 )	75.00 ( 25.624 )
Emotional Functioning: Cycle 22 (n=11,11)	75.76 ( 30.834 )	78.03 ( 22.445 )
Emotional Functioning: Cycle 23 (n=11,10)	74.24 ( 30.834 )	75.00 ( 27.778 )
Emotional Functioning: Cycle 24 (n=10,10)	71.67 ( 28.921 )	76.67 ( 22.153 )
Emotional Functioning: Cycle 25 (n=10,8)	65.83 ( 33.206 )	66.67 ( 29.881 )
Emotional Functioning: Cycle 26 (n=7,7)	71.43 ( 34.979 )	77.38 ( 17.156 )
Emotional Functioning: Cycle 27 (n=6,8)	56.94 ( 32.667 )	68.75 ( 29.124 )
Emotional Functioning: Cycle 28 (n=7,8)	65.48 ( 34.166 )	68.75 ( 29.463 )
Emotional Functioning: Cycle 29 (n=5,7)	68.33 ( 29.698 )	71.43 ( 31.127 )
Emotional Functioning: Cycle 30 (n=4,7)	72.92 ( 29.950 )	70.24 ( 31.497 )
Emotional Functioning: Cycle 31 (n=2,7)	45.83 ( 17.678 )	72.62 ( 26.227 )
Emotional Functioning: Cycle 32 (n=3,6)	69.44 ( 29.266 )	69.44 ( 33.610 )
Emotional Functioning: Cycle 33 (n=3,6)	77.78 ( 19.245 )	70.83 ( 27.764 )
Emotional Functioning: Cycle 34 (n=3,6)	66.67 ( 33.333 )	66.67 ( 34.561 )
Emotional Functioning: Cycle 35 (n=2,6)	83.33 ( 23.570 )	68.06 ( 33.918 )
Emotional Functioning: Cycle 36 (n=1,5)	100.00 ( 99999 )	71.67 ( 31.513 )
Emotional Functioning: Cycle 37 (n=1,4)	100.00 ( 99999 )	77.08 ( 35.600 )
Emotional Functioning: Cycle 38 (n=0,4)	99999 ( 99999 )	70.83 ( 42.219 )
Emotional Functioning: Cycle 39 (n=1,3)	100.00 ( 99999 )	63.89 ( 48.829 )
Emotional Functioning: Cycle 40(n=1,3)	100.00 ( 99999 )	66.67 ( 38.188 )
Emotional Functioning: Cycle 41(n=0,3)	99999 ( 99999 )	58.33 ( 41.667 )
Emotional Functioning: Cycle 42(n=0,2)	99999 ( 99999 )	54.17 ( 64.818 )
Emotional Functioning: Cycle 43(n=0,1)	99999 ( 99999 )	100.00 ( 99999 )
Emotional Functioning: EOT (n=33,30)	67.17 ( 23.748 )	66.94 ( 27.024 )
Cognitive Functioning: Cycle 1 (n=61,43)	90.16 ( 15.329 )	88.76 ( 15.310 )
Cognitive Functioning: Cycle 2 (n=57,41)	88.89 ( 15.537 )	89.43 ( 13.310 )
Cognitive Functioning: Cycle 3 (n=55,40)	89.09 ( 15.119 )	87.50 ( 19.882 )
Cognitive Functioning: Cycle 4 (n=50,38)	89.67 ( 12.993 )	87.72 ( 15.346 )
Cognitive Functioning: Cycle 5 (n=47,34)	88.65 ( 15.583 )	85.29 ( 22.385 )
Cognitive Functioning: Cycle 6 (n=43,31)	89.53 ( 15.006 )	82.80 ( 25.993 )
Cognitive Functioning: Cycle 7 (n=39,29)	89.74 ( 14.618 )	85.06 ( 20.091 )
Cognitive Functioning: Cycle 8 (n=37,25)	87.39 ( 13.836 )	83.33 ( 21.517 )
Cognitive Functioning: Cycle 9 (n=35,26)	88.10 ( 16.455 )	85.26 ( 20.181 )
Cognitive Functioning: Cycle 10 (n=35,23)	88.10 ( 13.750 )	83.33 ( 21.320 )
Cognitive Functioning: Cycle 11 (n=35,24)	86.67 ( 16.068 )	86.11 ( 17.492 )
Cognitive Functioning: Cycle 12 (n=35,22)	86.67 ( 13.886 )	86.36 ( 18.993 )
Cognitive Functioning: Cycle 13 (n=34,21)	87.25 ( 15.922 )	85.71 ( 19.211 )
Cognitive Functioning: Cycle 14 (n=31,19)	88.71 ( 13.185 )	77.19 ( 22.368 )
Cognitive Functioning: Cycle 15 (n=30,17)	88.33 ( 12.495 )	80.39 ( 27.154 )
Cognitive Functioning: Cycle 16 (n=27,16)	88.27 ( 12.067 )	80.21 ( 24.509 )
Cognitive Functioning: Cycle 17 (n=22,15)	89.39 ( 12.112 )	84.44 ( 20.380 )
Cognitive Functioning: Cycle 18 (n=17,14)	88.24 ( 14.148 )	79.76 ( 24.615 )
Cognitive Functioning: Cycle 19 (n=12,14)	88.89 ( 12.975 )	78.57 ( 24.832 )
Cognitive Functioning: Cycle 20 (n=11,13)	90.91 ( 11.459 )	82.05 ( 24.964 )
Cognitive Functioning: Cycle 21 (n=11,12)	89.39 ( 11.237 )	76.39 ( 26.071 )
Cognitive Functioning: Cycle 22 (n=11,11)	86.36 ( 12.513 )	81.82 ( 20.350 )
Cognitive Functioning: Cycle 23 (n=11,10)	84.85 ( 11.677 )	76.67 ( 27.442 )
Cognitive Functioning: Cycle 24 (n=10,10)	85.00 ( 16.574 )	81.67 ( 19.954 )
Cognitive Functioning: Cycle 25 (n=10,8)	81.67 ( 18.342 )	75.00 ( 25.198 )
Cognitive Functioning: Cycle 26(n=7,7)	85.71 ( 20.250 )	85.71 ( 17.817 )
Cognitive Functioning: Cycle 27(n=6,8)	75.00 ( 20.412 )	77.08 ( 25.099 )
Cognitive Functioning: Cycle 28(n=7,8)	76.19 ( 18.898 )	72.92 ( 29.463 )
Cognitive Functioning: Cycle 29(n=5,7)	76.67 ( 14.907 )	78.57 ( 26.726 )
Cognitive Functioning: Cycle 30(n=4,7)	75.00 ( 16.667 )	76.19 ( 31.706 )
Cognitive Functioning: Cycle 31(n=2,7)	83.33 ( 23.570 )	73.81 ( 31.706 )
Cognitive Functioning: Cycle 32(n=3,6)	83.33 ( 16.667 )	69.44 ( 32.347 )
Cognitive Functioning: Cycle 33(n=3,6)	88.89 ( 19.245 )	69.44 ( 26.701 )
Cognitive Functioning: Cycle 34(n=3,6)	77.78 ( 9.623 )	66.67 ( 34.960 )
Cognitive Functioning: Cycle 35(n=2,6)	100.00 ( 0.000 )	75.00 ( 27.386 )
Cognitive Functioning: Cycle 36(n=1,5)	100.00 ( 99999 )	73.33 ( 34.561 )
Cognitive Functioning: Cycle 37(n=1,4)	100.00 ( 99999 )	75.00 ( 39.675 )
Cognitive Functioning: Cycle 38(n=0,4)	99999 ( 99999 )	70.83 ( 47.871 )
Cognitive Functioning: Cycle 39(n=1,3)	100.00 ( 99999 )	72.22 ( 34.694 )
Cognitive Functioning: Cycle 40(n=1,3)	83.33 ( 99999 )	61.11 ( 34.694 )
Cognitive Functioning: Cycle 41(n=0,3)	99999 ( 99999 )	61.11 ( 41.944 )
Cognitive Functioning: Cycle 42(n=0,2)	99999 ( 99999 )	50.00 ( 70.711 )
Cognitive Functioning: Cycle 43(n=0,1)	99999 ( 99999 )	100.00 ( 99999 )
Cognitive Functioning: EOT (n=33,30)	83.33 ( 17.180 )	78.33 ( 23.631 )
Social Functioning: Cycle 1 (n=61,43)	80.87 ( 23.734 )	79.46 ( 25.675 )
Social Functioning: Cycle 2 (n=57,41)	83.04 ( 20.288 )	82.93 ( 20.578 )
Social Functioning: Cycle 3 (n=55,40)	79.09 ( 23.399 )	77.08 ( 26.335 )
Social Functioning: Cycle 4 (n=50,38)	81.67 ( 21.626 )	79.82 ( 25.160 )
Social Functioning: Cycle 5 (n=47,34)	80.85 ( 21.697 )	79.41 ( 26.291 )
Social Functioning: Cycle 6 (n=43,31)	80.23 ( 28.232 )	77.42 ( 28.398 )
Social Functioning: Cycle 7 (n=39,29)	80.34 ( 22.579 )	83.91 ( 27.271 )
Social Functioning: Cycle 8 (n=37,25)	78.83 ( 21.748 )	80.00 ( 25.909 )
Social Functioning: Cycle 9 (n=35,26)	77.62 ( 24.234 )	82.05 ( 23.534 )
Social Functioning: Cycle 10 (n=35,23)	81.43 ( 20.119 )	76.81 ( 26.939 )
Social Functioning: Cycle 11 (n=35,24)	76.19 ( 23.321 )	81.25 ( 26.151 )
Social Functioning: Cycle 12 (n=35,22)	75.71 ( 25.030 )	81.82 ( 27.172 )
Social Functioning: Cycle 13 (n=34,21)	77.94 ( 25.859 )	84.92 ( 21.670 )
Social Functioning: Cycle 14 (n=31,19)	81.18 ( 20.968 )	79.82 ( 29.700 )
Social Functioning: Cycle 15 (n=30,17)	76.67 ( 19.865 )	74.51 ( 31.797 )
Social Functioning: Cycle 16 (n=27,16)	75.93 ( 24.167 )	77.08 ( 25.000 )
Social Functioning: Cycle 17 (n=22,15)	75.00 ( 25.066 )	75.56 ( 25.871 )
Social Functioning: Cycle 18 (n=17,14)	76.47 ( 27.041 )	82.14 ( 28.090 )
Social Functioning: Cycle 19 (n=12,14)	72.22 ( 24.958 )	77.38 ( 26.640 )
Social Functioning: Cycle 20 (n=11,13)	75.76 ( 30.151 )	83.33 ( 21.517 )
Social Functioning: Cycle 21 (n=11,12)	71.21 ( 28.955 )	81.94 ( 26.071 )
Social Functioning: Cycle 22 (n=11,11)	69.70 ( 33.181 )	75.76 ( 30.151 )
Social Functioning: Cycle 23 (n=11,10)	71.21 ( 30.814 )	78.33 ( 31.476 )
Social Functioning: Cycle 24 (n=10,10)	63.33 ( 32.203 )	76.67 ( 30.631 )
Social Functioning: Cycle 25 (n=10,8)	70.00 ( 39.126 )	66.67 ( 34.503 )
Social Functioning: Cycle 26 (n=7,7)	61.90 ( 34.311 )	88.10 ( 15.853 )
Social Functioning: Cycle 27 (n=6,8)	58.33 ( 32.914 )	70.83 ( 33.034 )
Social Functioning: Cycle 28 (n=7,8)	73.81 ( 38.318 )	77.08 ( 28.084 )
Social Functioning: Cycle 29 (n=5,7)	80.00 ( 18.257 )	71.43 ( 34.311 )
Social Functioning: Cycle 30 (n=4,7)	75.00 ( 31.914 )	69.05 ( 36.551 )
Social Functioning: Cycle 31 (n=2,7)	66.67 ( 47.140 )	71.43 ( 35.635 )
Social Functioning: Cycle 32 (n=3,6)	77.78 ( 19.245 )	66.67 ( 36.515 )
Social Functioning: Cycle 33 (n=3,6)	66.67 ( 0.000 )	69.44 ( 30.581 )
Social Functioning: Cycle 34 (n=3,6)	66.67 ( 0.000 )	63.89 ( 37.143 )
Social Functioning: Cycle 35 (n=2,6)	66.67 ( 23.570 )	72.22 ( 37.515 )
Social Functioning: Cycle 36 (n=1,5)	100.00 ( 99999 )	53.33 ( 36.132 )
Social Functioning: Cycle 37 (n=1,4)	66.67 ( 99999 )	58.33 ( 41.944 )
Social Functioning: Cycle 38 (n=0,4)	99999 ( 99999 )	66.67 ( 36.004 )
Social Functioning: Cycle 39 (n=1,3)	100.00 ( 99999 )	44.44 ( 38.490 )
Social Functioning: Cycle 40 (n=1,3)	66.67 ( 99999 )	61.11 ( 38.490 )
Social Functioning: Cycle 41 (n=0,3)	99999 ( 99999 )	44.44 ( 25.459 )
Social Functioning: Cycle 42 (n=0,2)	99999 ( 99999 )	41.67 ( 35.355 )
Social Functioning: Cycle 43 (n=0,1)	99999 ( 99999 )	66.67 ( 99999 )
Social Functioning: EOT (n=33,30)	73.74 ( 25.355 )	65.00 ( 29.148 )
Fatigue: Cycle 1 (n=61,44)	21.49 ( 20.374 )	29.42 ( 17.835 )
Fatigue: Cycle 2 (n=57,42)	24.37 ( 17.995 )	29.10 ( 19.001 )
Fatigue: Cycle 3 (n=55,40)	26.46 ( 19.303 )	30.28 ( 22.644 )
Fatigue: Cycle 4 (n=50,38)	24.00 ( 18.424 )	29.53 ( 24.133 )
Fatigue: Cycle 5 (n=47,34)	26.00 ( 17.069 )	27.61 ( 23.865 )
Fatigue: Cycle 6 (n=43,31)	25.32 ( 17.029 )	29.93 ( 25.526 )
Fatigue: Cycle 7 (n=39,29)	26.78 ( 21.284 )	28.35 ( 24.232 )
Fatigue: Cycle 8 (n=37,25)	27.63 ( 17.297 )	23.11 ( 18.681 )
Fatigue: Cycle 9 (n=35,26)	26.35 ( 20.182 )	22.22 ( 20.608 )
Fatigue: Cycle 10 (n=35,23)	26.03 ( 19.975 )	24.64 ( 23.914 )
Fatigue: Cycle 11 (n=35,24)	27.94 ( 18.548 )	22.45 ( 20.624 )
Fatigue: Cycle 12 (n=35,22)	26.35 ( 20.001 )	22.22 ( 23.256 )
Fatigue: Cycle 13 (n=34,21)	25.16 ( 19.012 )	18.52 ( 15.045 )
Fatigue: Cycle 14 (n=31,19)	24.73 ( 19.183 )	24.56 ( 20.813 )
Fatigue: Cycle 15 (n=30,17)	24.07 ( 20.443 )	24.84 ( 24.066 )
Fatigue: Cycle 16 (n=27,16)	27.16 ( 23.937 )	22.92 ( 17.902 )
Fatigue: Cycle 17 (n=22,15)	28.28 ( 22.150 )	18.52 ( 18.144 )
Fatigue: Cycle 18 (n=17,14)	26.80 ( 22.243 )	22.22 ( 17.433 )
Fatigue: Cycle 19 (n=12,14)	34.26 ( 31.944 )	23.02 ( 20.191 )
Fatigue: Cycle 20 (n=11,13)	34.34 ( 26.036 )	22.22 ( 18.144 )
Fatigue: Cycle 21 (n=11,12)	34.34 ( 32.377 )	28.70 ( 21.429 )
Fatigue: Cycle 22 (n=11,11)	31.31 ( 28.029 )	30.30 ( 27.707 )
Fatigue: Cycle 23 (n=11,10)	39.39 ( 28.702 )	28.89 ( 25.229 )
Fatigue: Cycle 24 (n=10,10)	36.67 ( 32.309 )	28.89 ( 26.294 )
Fatigue: Cycle 25 (n=10,8)	40.00 ( 30.180 )	27.78 ( 21.414 )
Fatigue: Cycle 26 (n=7,7)	44.44 ( 27.962 )	22.22 ( 14.344 )
Fatigue: Cycle 27 (n=6,8)	50.00 ( 30.429 )	26.39 ( 22.954 )
Fatigue: Cycle 28 (n=7,8)	42.86 ( 28.276 )	30.56 ( 26.394 )
Fatigue: Cycle 29 (n=6,7)	35.19 ( 23.744 )	28.57 ( 21.138 )
Fatigue: Cycle 30 (n=5,7)	24.44 ( 18.257 )	31.75 ( 27.539 )
Fatigue: Cycle 31 (n=3,7)	22.22 ( 29.397 )	31.75 ( 29.696 )
Fatigue: Cycle 32 (n=3,6)	18.52 ( 23.130 )	35.19 ( 12.989 )
Fatigue: Cycle 33 (n=3,6)	22.22 ( 29.397 )	40.74 ( 20.688 )
Fatigue: Cycle 34 (n=3,6)	37.04 ( 35.717 )	40.74 ( 16.728 )
Fatigue: Cycle 35 (n=2,6)	33.33 ( 47.140 )	35.19 ( 16.355 )
Fatigue: Cycle 36 (n=1,5)	0.00 ( 99999 )	40.00 ( 14.907 )
Fatigue: Cycle 37 (n=1,4)	0.00 ( 99999 )	36.11 ( 21.033 )
Fatigue: Cycle 38 (n=0,4)	99999 ( 99999 )	44.44 ( 27.217 )
Fatigue: Cycle 39 (n=1,3)	0.00 ( 99999 )	51.85 ( 33.945 )
Fatigue: Cycle 40 (n=1,3)	0.00 ( 99999 )	59.26 ( 33.945 )
Fatigue: Cycle 41 (n=0,3)	99999 ( 99999 )	48.15 ( 23.130 )
Fatigue: Cycle 42 (n=0,2)	99999 ( 99999 )	44.44 ( 31.427 )
Fatigue: Cycle 43 (n=0,1)	99999 ( 99999 )	22.22 ( 99999 )
Fatigue: EOT (n=33,30)	33.00 ( 23.812 )	40.56 ( 28.632 )
Nausea and Vomiting: Cycle 1 (n=61,44)	6.56 ( 13.010 )	7.95 ( 17.420 )
Nausea and Vomiting: Cycle 2 (n=57,42)	7.31 ( 12.206 )	7.14 ( 9.123 )
Nausea and Vomiting: Cycle 3 (n=55,40)	7.27 ( 12.735 )	12.08 ( 19.967 )
Nausea and Vomiting: Cycle 4 (n=50,38)	8.00 ( 13.569 )	4.39 ( 9.238 )
Nausea and Vomiting: Cycle 5 (n=47,34)	6.38 ( 12.794 )	8.33 ( 14.935 )
Nausea and Vomiting: Cycle 6 (n=43,31)	6.98 ( 12.189 )	6.99 ( 11.200 )
Nausea and Vomiting: Cycle 7 (n=39,29)	6.41 ( 12.458 )	6.90 ( 15.117 )
Nausea and Vomiting: Cycle 8 (n=37,25)	7.66 ( 15.513 )	3.33 ( 6.804 )
Nausea and Vomiting: Cycle 9 (n=35,26)	9.05 ( 14.766 )	4.49 ( 10.064 )
Nausea and Vomiting: Cycle 10 (n=35,23)	5.71 ( 12.088 )	4.35 ( 9.014 )
Nausea and Vomiting: Cycle 11 (n=35,24)	4.76 ( 10.362 )	4.86 ( 9.167 )
Nausea and Vomiting: Cycle 12 (n=35,22)	4.76 ( 11.835 )	6.06 ( 8.206 )
Nausea and Vomiting: Cycle 13 (n=34,21)	3.43 ( 8.970 )	2.38 ( 5.976 )
Nausea and Vomiting: Cycle 14 (n=31,19)	5.38 ( 9.988 )	6.14 ( 12.681 )
Nausea and Vomiting: Cycle 15 (n=30,17)	7.22 ( 12.132 )	5.88 ( 16.605 )
Nausea and Vomiting: Cycle 16 (n=27,16)	4.32 ( 9.906 )	3.13 ( 9.065 )
Nausea and Vomiting: Cycle 17 (n=22,15)	3.03 ( 8.351 )	4.44 ( 9.894 )
Nausea and Vomiting: Cycle 18 (n=17,14)	4.90 ( 11.433 )	1.19 ( 4.454 )
Nausea and Vomiting: Cycle 19 (n=12,14)	4.17 ( 10.360 )	4.76 ( 12.105 )
Nausea and Vomiting: Cycle 20 (n=11,13)	6.06 ( 15.407 )	1.28 ( 4.623 )
Nausea and Vomiting: Cycle 21 (n=11,12)	4.55 ( 15.076 )	6.94 ( 19.408 )
Nausea and Vomiting: Cycle 22 (n=11,11)	4.55 ( 15.076 )	9.09 ( 30.151 )
Nausea and Vomiting: Cycle 23 (n=11,10)	6.06 ( 15.407 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 24 (n=10,10)	6.67 ( 11.653 )	3.33 ( 7.027 )
Nausea and Vomiting: Cycle 25 (n=10,8)	8.33 ( 14.164 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 26 (n=7,7)	7.14 ( 8.909 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 27 (n=6,8)	11.11 ( 20.184 )	4.17 ( 11.785 )
Nausea and Vomiting: Cycle 28 (n=7,8)	9.52 ( 18.898 )	2.08 ( 5.893 )
Nausea and Vomiting: Cycle 29 (n=6,7)	2.78 ( 6.804 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 30 (n=5,7)	0.00 ( 0.000 )	2.38 ( 6.299 )
Nausea and Vomiting: Cycle 31 (n=3,7)	0.00 ( 0.000 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 32 (n=3,6)	5.56 ( 9.623 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 33 (n=3,6)	22.22 ( 38.490 )	2.78 ( 6.804 )
Nausea and Vomiting: Cycle 34 (n=3,6)	22.22 ( 38.490 )	8.33 ( 13.944 )
Nausea and Vomiting: Cycle 35 (n=2,6)	16.67 ( 23.570 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 36 (n=1,5)	0.00 ( 99999 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 37 (n=1,4)	0.00 ( 99999 )	4.17 ( 8.333 )
Nausea and Vomiting: Cycle 38 (n=0,4)	99999 ( 99999 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 39 (n=1,3)	0.00 ( 99999 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 40 (n=1,3)	0.00 ( 99999 )	11.11 ( 19.245 )
Nausea and Vomiting: Cycle 41 (n=0,3)	99999 ( 99999 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 42 (n=0,2)	99999 ( 99999 )	0.00 ( 0.000 )
Nausea and Vomiting: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Nausea and Vomiting: EOT (n=33,30)	16.16 ( 21.844 )	12.78 ( 20.846 )
Pain: Cycle 1 (n=61,44)	16.39 ( 20.067 )	18.18 ( 18.958 )
Pain: Cycle 2 (n=57,42)	16.67 ( 18.094 )	19.05 ( 20.353 )
Pain: Cycle 3 (n=55,40)	15.76 ( 18.542 )	22.50 ( 27.099 )
Pain: Cycle 4 (n=50,38)	14.00 ( 15.922 )	23.25 ( 24.056 )
Pain: Cycle 5 (n=47,34)	15.96 ( 16.651 )	18.14 ( 22.235 )
Pain: Cycle 6 (n=43,31)	15.89 ( 17.041 )	20.43 ( 26.073 )
Pain: Cycle 7 (n=39,29)	20.09 ( 21.690 )	22.99 ( 22.893 )
Pain: Cycle 8 (n=37,25)	17.57 ( 17.099 )	14.67 ( 16.887 )
Pain: Cycle 9 (n=35,26)	20.48 ( 19.838 )	19.87 ( 19.447 )
Pain: Cycle 10 (n=35,23)	19.52 ( 22.682 )	18.84 ( 22.079 )
Pain: Cycle 11 (n=35,24)	19.05 ( 19.446 )	13.89 ( 18.169 )
Pain: Cycle 12 (n=35,22)	20.48 ( 22.172 )	16.67 ( 17.817 )
Pain: Cycle 13 (n=34,21)	17.16 ( 15.616 )	15.87 ( 20.053 )
Pain: Cycle 14 (n=31,19)	14.52 ( 17.074 )	21.05 ( 19.909 )
Pain: Cycle 15 (n=30,17)	15.00 ( 23.305 )	21.57 ( 24.127 )
Pain: Cycle 16 (n=27,16)	17.28 ( 21.917 )	15.63 ( 14.232 )
Pain: Cycle 17 (n=22,15)	18.94 ( 23.171 )	15.56 ( 17.213 )
Pain: Cycle 18 (n=17,14)	16.67 ( 22.048 )	10.71 ( 16.803 )
Pain: Cycle 19 (n=12,14)	26.39 ( 27.941 )	13.10 ( 16.249 )
Pain: Cycle 20 (n=11,13)	25.76 ( 27.247 )	12.82 ( 15.447 )
Pain: Cycle 21 (n=11,12)	25.76 ( 29.215 )	16.67 ( 21.320 )
Pain: Cycle 22 (n=11,11)	18.18 ( 26.304 )	21.21 ( 21.201 )
Pain: Cycle 23 (n=11,10)	21.21 ( 27.979 )	15.00 ( 22.839 )
Pain: Cycle 24 (n=10,10)	28.33 ( 26.117 )	20.00 ( 24.595 )
Pain: Cycle 25 (n=10,8)	26.67 ( 30.631 )	16.67 ( 19.920 )
Pain: Cycle 26 (n=7,7)	38.10 ( 40.500 )	16.67 ( 19.245 )
Pain: Cycle 27 (n=6,8)	47.22 ( 35.616 )	20.83 ( 21.362 )
Pain: Cycle 28 (n=7,8)	35.71 ( 33.923 )	22.92 ( 25.099 )
Pain: Cycle 29 (n=6,7)	19.44 ( 19.484 )	23.81 ( 26.972 )
Pain: Cycle 30 (n=5,7)	20.00 ( 21.731 )	19.05 ( 24.398 )
Pain: Cycle 31 (n=3,7)	16.67 ( 28.868 )	26.19 ( 23.288 )
Pain: Cycle 32 (n=3,6)	16.67 ( 28.868 )	27.78 ( 31.032 )
Pain: Cycle 33 (n=3,6)	16.67 ( 28.868 )	25.00 ( 25.276 )
Pain: Cycle 34 (n=3,6)	22.22 ( 38.490 )	27.78 ( 25.092 )
Pain: Cycle 35 (n=2,6)	25.00 ( 35.355 )	22.22 ( 13.608 )
Pain: Cycle 36 (n=1,5)	0.00 ( 99999 )	20.00 ( 13.944 )
Pain: Cycle 37 (n=1,4)	16.67 ( 99999 )	29.17 ( 28.464 )
Pain: Cycle 38 (n=0,4)	99999 ( 99999 )	29.17 ( 28.464 )
Pain: Cycle 39 (n=1,3)	0.00 ( 99999 )	38.89 ( 25.459 )
Pain: Cycle 40 (n=1,3)	0.00 ( 99999 )	44.44 ( 19.245 )
Pain: Cycle 41 (n=0,3)	99999 ( 99999 )	55.56 ( 41.944 )
Pain: Cycle 42 (n=0,2)	99999 ( 99999 )	33.33 ( 47.140 )
Pain: Cycle 43 (n=0,1)	99999 ( 99999 )	33.33 ( 99999 )
Pain: EOT (n=33,30)	23.74 ( 25.695 )	33.89 ( 32.009 )
Dyspnoea: Cycle 1 (n=60,44)	5.00 ( 12.003 )	7.58 ( 15.854 )
Dyspnoea: Cycle 2 (n=57,42)	7.02 ( 15.088 )	8.73 ( 18.123 )
Dyspnoea: Cycle 3 (n=55,40)	6.06 ( 12.975 )	9.17 ( 21.334 )
Dyspnoea: Cycle 4 (n=50,38)	6.00 ( 12.936 )	13.16 ( 21.280 )
Dyspnoea: Cycle 5 (n=47,34)	5.67 ( 14.445 )	10.78 ( 22.801 )
Dyspnoea: Cycle 6 (n=43,31)	6.98 ( 15.530 )	10.75 ( 24.925 )
Dyspnoea: Cycle 7 (n=39,29)	11.11 ( 22.076 )	10.34 ( 20.125 )
Dyspnoea: Cycle 8 (n=37,25)	15.32 ( 21.652 )	6.67 ( 13.608 )
Dyspnoea: Cycle 9 (n=35,26)	9.52 ( 20.725 )	5.13 ( 12.265 )
Dyspnoea: Cycle 10 (n=35,23)	9.52 ( 15.278 )	10.14 ( 21.165 )
Dyspnoea: Cycle 11 (n=35,24)	5.71 ( 12.746 )	9.72 ( 15.477 )
Dyspnoea: Cycle 12 (n=35,22)	8.57 ( 14.781 )	6.06 ( 13.159 )
Dyspnoea: Cycle 13 (n=34,21)	10.78 ( 15.829 )	12.70 ( 19.653 )
Dyspnoea: Cycle 14 (n=31,19)	9.68 ( 15.380 )	8.77 ( 15.080 )
Dyspnoea: Cycle 15 (n=30,17)	8.89 ( 14.993 )	9.80 ( 15.656 )
Dyspnoea: Cycle 16 (n=27,16)	6.17 ( 13.195 )	6.25 ( 13.437 )
Dyspnoea: Cycle 17 (n=22,15)	10.61 ( 15.891 )	6.67 ( 13.801 )
Dyspnoea: Cycle 18 (n=17,14)	7.84 ( 14.575 )	4.76 ( 12.105 )
Dyspnoea: Cycle 19 (n=12,14)	13.89 ( 17.164 )	4.76 ( 12.105 )
Dyspnoea: Cycle 20 (n=11,13)	6.06 ( 13.484 )	5.13 ( 12.518 )
Dyspnoea: Cycle 21 (n=11,12)	12.12 ( 16.817 )	8.33 ( 15.076 )
Dyspnoea: Cycle 22 (n=11,11)	9.09 ( 15.570 )	9.09 ( 15.570 )
Dyspnoea: Cycle 23 (n=11,10)	6.06 ( 13.484 )	13.33 ( 17.213 )
Dyspnoea: Cycle 24 (n=10,10)	6.67 ( 14.055 )	13.33 ( 17.213 )
Dyspnoea: Cycle 25 (n=10,8)	13.33 ( 23.307 )	8.33 ( 15.430 )
Dyspnoea: Cycle 26 (n=7,7)	9.52 ( 16.265 )	9.52 ( 16.265 )
Dyspnoea: Cycle 27 (n=6,8)	11.11 ( 27.217 )	8.33 ( 15.430 )
Dyspnoea: Cycle 28 (n=7,8)	19.05 ( 17.817 )	12.50 ( 17.252 )
Dyspnoea: Cycle 29 (n=6,7)	11.11 ( 27.217 )	19.05 ( 17.817 )
Dyspnoea: Cycle 30 (n=5,7)	6.67 ( 14.907 )	14.29 ( 17.817 )
Dyspnoea: Cycle 31 (n=3,7)	0.00 ( 0.000 )	9.52 ( 16.265 )
Dyspnoea: Cycle 32 (n=3,6)	11.11 ( 19.245 )	16.67 ( 27.889 )
Dyspnoea: Cycle 33 (n=3,6)	22.22 ( 38.490 )	11.11 ( 17.213 )
Dyspnoea: Cycle 34 (n=3,6)	11.11 ( 19.245 )	16.67 ( 27.889 )
Dyspnoea: Cycle 35 (n=2,6)	16.67 ( 23.570 )	11.11 ( 17.213 )
Dyspnoea: Cycle 36 (n=1,5)	0.00 ( 99999 )	26.67 ( 27.889 )
Dyspnoea: Cycle 37 (n=1,4)	0.00 ( 99999 )	8.33 ( 16.667 )
Dyspnoea: Cycle 38 (n=0,4)	99999 ( 99999 )	8.33 ( 16.667 )
Dyspnoea: Cycle 39 (n=1,3)	0.00 ( 99999 )	0.00 ( 0.000 )
Dyspnoea: Cycle 40 (n=1,3)	0.00 ( 99999 )	0.00 ( 0.000 )
Dyspnoea: Cycle 41 (n=0,3)	99999 ( 99999 )	0.00 ( 0.000 )
Dyspnoea: Cycle 42 (n=0,2)	99999 ( 99999 )	16.67 ( 23.570 )
Dyspnoea: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Dyspnoea: EOT (n=33,30)	14.14 ( 16.730 )	13.33 ( 24.132 )
Insomnia: Cycle 1 (n=61,44)	13.11 ( 20.438 )	25.76 ( 27.715 )
Insomnia: Cycle 2 (n=57,42)	9.36 ( 16.372 )	19.84 ( 23.350 )
Insomnia: Cycle 3 (n=55,40)	12.12 ( 17.408 )	26.67 ( 26.366 )
Insomnia: Cycle 4 (n=50,38)	11.33 ( 19.760 )	24.56 ( 27.601 )
Insomnia: Cycle 5 (n=47,34)	9.22 ( 19.289 )	17.65 ( 26.253 )
Insomnia: Cycle 6 (n=43,31)	10.85 ( 18.857 )	20.43 ( 26.774 )
Insomnia: Cycle 7 (n=39,29)	9.40 ( 18.651 )	21.84 ( 28.558 )
Insomnia: Cycle 8 (n=37,25)	10.81 ( 20.867 )	21.33 ( 21.257 )
Insomnia: Cycle 9 (n=35,26)	11.43 ( 19.708 )	20.51 ( 23.242 )
Insomnia: Cycle 10 (n=35,23)	12.38 ( 18.232 )	21.74 ( 21.576 )
Insomnia: Cycle 11 (n=35,24)	12.38 ( 18.232 )	22.22 ( 27.217 )
Insomnia: Cycle 12 (n=35,22)	6.67 ( 15.760 )	22.73 ( 27.958 )
Insomnia: Cycle 13 (n=34,21)	9.80 ( 15.417 )	23.81 ( 21.455 )
Insomnia: Cycle 14 (n=31,19)	8.60 ( 17.144 )	22.81 ( 19.413 )
Insomnia: Cycle 15 (n=29,17)	9.20 ( 17.586 )	25.49 ( 25.082 )
Insomnia: Cycle 16 (n=27,16)	9.88 ( 20.286 )	25.00 ( 28.545 )
Insomnia: Cycle 17 (n=22,15)	6.06 ( 16.703 )	22.22 ( 24.125 )
Insomnia: Cycle 18 (n=17,14)	11.76 ( 16.420 )	23.81 ( 24.209 )
Insomnia: Cycle 19 (n=12,14)	13.89 ( 22.285 )	23.81 ( 24.209 )
Insomnia: Cycle 20 (n=11,13)	9.09 ( 15.570 )	25.64 ( 24.167 )
Insomnia: Cycle 21 (n=11,12)	18.18 ( 22.918 )	30.56 ( 26.432 )
Insomnia: Cycle 22 (n=11,11)	15.15 ( 22.918 )	30.30 ( 27.707 )
Insomnia: Cycle 23 (n=11,10)	15.15 ( 17.408 )	30.00 ( 33.148 )
Insomnia: Cycle 24 (n=10,10)	10.00 ( 22.498 )	33.33 ( 27.217 )
Insomnia: Cycle 25 (n=10,8)	23.33 ( 27.442 )	29.17 ( 27.817 )
Insomnia: Cycle 26 (n=7,7)	9.52 ( 16.265 )	23.81 ( 25.198 )
Insomnia: Cycle 27 (n=6,8)	27.78 ( 38.968 )	33.33 ( 25.198 )
Insomnia: Cycle 28 (n=7,8)	23.81 ( 25.198 )	25.00 ( 29.547 )
Insomnia: Cycle 29 (n=6,7)	22.22 ( 27.217 )	38.10 ( 35.635 )
Insomnia: Cycle 30 (n=5,7)	6.67 ( 14.907 )	28.57 ( 29.991 )
Insomnia: Cycle 31 (n=3,7)	11.11 ( 19.245 )	19.05 ( 26.227 )
Insomnia: Cycle 32 (n=3,6)	22.22 ( 19.245 )	27.78 ( 25.092 )
Insomnia: Cycle 33 (n=3,6)	22.22 ( 19.245 )	22.22 ( 27.217 )
Insomnia: Cycle 34 (n=3,6)	22.22 ( 38.490 )	27.78 ( 25.092 )
Insomnia: Cycle 35 (n=2,6)	16.67 ( 23.570 )	27.78 ( 25.092 )
Insomnia: Cycle 36 (n=1,5)	0.00 ( 99999 )	26.67 ( 27.889 )
Insomnia: Cycle 37 (n=1,4)	0.00 ( 99999 )	16.67 ( 19.245 )
Insomnia: Cycle 38 (n=0,4)	99999 ( 99999 )	33.33 ( 27.217 )
Insomnia: Cycle 39 (n=1,3)	0.00 ( 99999 )	22.22 ( 19.245 )
Insomnia: Cycle 40 (n=1,3)	0.00 ( 99999 )	33.33 ( 0.000 )
Insomnia: Cycle 41 (n=0,3)	99999 ( 99999 )	22.22 ( 19.245 )
Insomnia: Cycle 42 (n=0,2)	99999 ( 99999 )	16.67 ( 23.570 )
Insomnia: Cycle 43 (n=0,1)	99999 ( 99999 )	33.33 ( 99999 )
Insomnia: EOT (n=33,30)	16.16 ( 26.512 )	25.56 ( 33.543 )
Appetite Loss: Cycle 1 (n=61,44)	12.57 ( 21.225 )	15.91 ( 23.282 )
Appetite Loss: Cycle 2 (n=57,42)	16.96 ( 21.009 )	18.25 ( 22.333 )
Appetite Loss: Cycle 3 (n=55,40)	13.94 ( 18.912 )	20.83 ( 28.929 )
Appetite Loss: Cycle 4 (n=50,38)	14.00 ( 24.365 )	16.67 ( 26.565 )
Appetite Loss: Cycle 5 (n=47,34)	10.64 ( 20.974 )	15.69 ( 28.704 )
Appetite Loss: Cycle 6 (n=43,31)	10.85 ( 20.212 )	18.28 ( 30.839 )
Appetite Loss: Cycle 7 (n=39,29)	14.53 ( 22.679 )	14.94 ( 28.986 )
Appetite Loss: Cycle 8 (n=37,25)	16.22 ( 25.606 )	14.67 ( 25.604 )
Appetite Loss: Cycle 9 (n=35,26)	14.29 ( 18.587 )	14.10 ( 26.954 )
Appetite Loss: Cycle 10 (n=35,23)	13.33 ( 21.693 )	17.39 ( 28.194 )
Appetite Loss: Cycle 11 (n=35,24)	15.24 ( 21.907 )	8.33 ( 22.522 )
Appetite Loss: Cycle 12 (n=35,22)	13.33 ( 25.820 )	12.12 ( 24.224 )
Appetite Loss: Cycle 13 (n=34,21)	13.73 ( 21.893 )	7.94 ( 14.548 )
Appetite Loss: Cycle 14 (n=31,19)	10.75 ( 21.751 )	10.53 ( 19.413 )
Appetite Loss: Cycle 15 (n=30,17)	13.33 ( 24.132 )	15.69 ( 29.149 )
Appetite Loss: Cycle 16 (n=27,16)	13.58 ( 23.130 )	8.33 ( 19.245 )
Appetite Loss: Cycle 17 (n=22,15)	10.61 ( 23.874 )	6.67 ( 18.687 )
Appetite Loss: Cycle 18 (n=17,14)	17.65 ( 29.149 )	9.52 ( 20.375 )
Appetite Loss: Cycle 19 (n=12,14)	19.44 ( 33.207 )	9.52 ( 27.514 )
Appetite Loss: Cycle 20 (n=11,13)	21.21 ( 34.230 )	5.13 ( 12.518 )
Appetite Loss: Cycle 21 (n=11,12)	21.21 ( 34.230 )	16.67 ( 22.473 )
Appetite Loss: Cycle 22 (n=11,11)	18.18 ( 31.140 )	15.15 ( 22.918 )
Appetite Loss: Cycle 23 (n=11,10)	18.18 ( 31.140 )	10.00 ( 22.498 )
Appetite Loss: Cycle 24 (n=10,10)	23.33 ( 35.312 )	13.33 ( 23.307 )
Appetite Loss: Cycle 25 (n=10,8)	23.33 ( 41.722 )	8.33 ( 23.570 )
Appetite Loss: Cycle 26 (n=7,7)	38.10 ( 48.795 )	4.76 ( 12.599 )
Appetite Loss: Cycle 27 (n=6,8)	33.33 ( 42.164 )	12.50 ( 35.355 )
Appetite Loss: Cycle 28 (n=7,8)	28.57 ( 40.500 )	16.67 ( 35.635 )
Appetite Loss: Cycle 29 (n=6,7)	11.11 ( 27.217 )	4.76 ( 12.599 )
Appetite Loss: Cycle 30 (n=5,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Appetite Loss: Cycle 31 (n=3,7)	0.00 ( 0.000 )	9.52 ( 25.198 )
Appetite Loss: Cycle 32 (n=3,6)	11.11 ( 19.245 )	16.67 ( 27.889 )
Appetite Loss: Cycle 33 (n=3,6)	22.22 ( 38.490 )	16.67 ( 27.889 )
Appetite Loss: Cycle 34 (n=3,6)	33.33 ( 57.735 )	27.78 ( 32.773 )
Appetite Loss: Cycle 35 (n=2,6)	33.33 ( 47.140 )	11.11 ( 27.217 )
Appetite Loss: Cycle 36 (n=1,5)	0.00 ( 99999 )	0.00 ( 0.000 )
Appetite Loss: Cycle 37 (n=1,4)	0.00 ( 99999 )	16.67 ( 19.245 )
Appetite Loss: Cycle 38 (n=0,4)	99999 ( 99999 )	16.67 ( 19.245 )
Appetite Loss: Cycle 39 (n=1,3)	0.00 ( 99999 )	11.11 ( 19.245 )
Appetite Loss: Cycle 40 (n=1,3)	0.00 ( 99999 )	11.11 ( 19.245 )
Appetite Loss: Cycle 41 (n=0,3)	99999 ( 99999 )	22.22 ( 38.490 )
Appetite Loss: Cycle 42 (n=0,2)	99999 ( 99999 )	16.67 ( 23.570 )
Appetite Loss: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Appetite Loss: EOT (n=33,30)	27.27 ( 34.816 )	26.67 ( 32.044 )
Constipation: Cycle 1 (n=61,44)	7.10 ( 17.336 )	9.09 ( 18.135 )
Constipation: Cycle 2 (n=57,42)	3.51 ( 10.321 )	13.49 ( 26.605 )
Constipation: Cycle 3 (n=55,40)	7.27 ( 15.303 )	4.17 ( 13.477 )
Constipation: Cycle 4 (n=50,38)	6.67 ( 15.058 )	5.26 ( 12.318 )
Constipation: Cycle 5 (n=47,34)	3.55 ( 12.499 )	2.94 ( 12.627 )
Constipation: Cycle 6 (n=43,31)	3.88 ( 10.812 )	2.15 ( 8.324 )
Constipation: Cycle 7 (n=39,29)	3.42 ( 10.245 )	5.75 ( 17.970 )
Constipation: Cycle 8 (n=37,25)	3.60 ( 13.109 )	4.00 ( 14.657 )
Constipation: Cycle 9 (n=35,26)	6.67 ( 15.760 )	3.85 ( 14.382 )
Constipation: Cycle 10 (n=35,23)	2.86 ( 9.468 )	5.80 ( 16.368 )
Constipation: Cycle 11 (n=35,24)	3.81 ( 13.459 )	2.78 ( 9.411 )
Constipation: Cycle 12 (n=35,22)	5.71 ( 12.746 )	4.55 ( 11.708 )
Constipation: Cycle 13 (n=34,21)	2.94 ( 9.597 )	1.59 ( 7.274 )
Constipation: Cycle 14 (n=31,19)	1.08 ( 5.987 )	3.51 ( 10.510 )
Constipation: Cycle 15 (n=30,17)	2.22 ( 8.457 )	3.92 ( 16.169 )
Constipation: Cycle 16 (n=27,16)	2.47 ( 8.896 )	6.25 ( 13.437 )
Constipation: Cycle 17 (n=22,15)	6.06 ( 13.159 )	2.22 ( 8.607 )
Constipation: Cycle 18 (n=17,14)	3.92 ( 11.070 )	4.76 ( 12.105 )
Constipation: Cycle 19 (n=12,14)	0.00 ( 0.000 )	9.52 ( 20.375 )
Constipation: Cycle 20 (n=11,13)	0.00 ( 0.000 )	0.00 ( 0.000 )
Constipation: Cycle 21 (n=11,12)	0.00 ( 0.000 )	2.78 ( 9.623 )
Constipation: Cycle 22 (n=11,11)	0.00 ( 0.000 )	12.12 ( 30.814 )
Constipation: Cycle 23 (n=11,10)	0.00 ( 0.000 )	3.33 ( 10.541 )
Constipation: Cycle 24 (n=10,10)	0.00 ( 0.000 )	6.67 ( 14.055 )
Constipation: Cycle 25 (n=10,8)	3.33 ( 10.541 )	0.00 ( 0.000 )
Constipation: Cycle 26 (n=7,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Constipation: Cycle 27 (n=6,8)	5.56 ( 13.608 )	4.17 ( 11.785 )
Constipation: Cycle 28 (n=7,8)	4.76 ( 12.599 )	4.17 ( 11.785 )
Constipation: Cycle 29 (n=5,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Constipation: Cycle 30 (n=4,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Constipation: Cycle 31 (n=2,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Constipation: Cycle 32 (n=3,6)	0.00 ( 0.000 )	0.00 ( 0.000 )
Constipation: Cycle 33 (n=3,6)	0.00 ( 0.000 )	5.56 ( 13.608 )
Constipation: Cycle 34 (n=3,6)	0.00 ( 0.000 )	5.56 ( 13.608 )
Constipation: Cycle 35 (n=2,6)	0.00 ( 0.000 )	5.56 ( 13.608 )
Constipation: Cycle 36 (n=1,5)	0.00 ( 99999 )	13.33 ( 29.814 )
Constipation: Cycle 37 (n=1,4)	0.00 ( 99999 )	0.00 ( 0.000 )
Constipation: Cycle 38 (n=0,4)	99999 ( 99999 )	0.00 ( 0.000 )
Constipation: Cycle 39 (n=1,3)	0.00 ( 99999 )	11.11 ( 19.245 )
Constipation: Cycle 40 (n=1,3)	0.00 ( 99999 )	0.00 ( 0.000 )
Constipation: Cycle 41 (n=0,3)	99999 ( 99999 )	0.00 ( 0.000 )
Constipation: Cycle 42 (n=0,2)	99999 ( 99999 )	0.00 ( 0.000 )
Constipation: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Constipation: EOT (n=33,30)	10.10 ( 19.516 )	3.33 ( 10.171 )
Diarrhoea: Cycle 1 (n=61,43)	14.21 ( 22.327 )	11.63 ( 17.644 )
Diarrhoea: Cycle 2 (n=57,41)	18.13 ( 26.027 )	17.07 ( 25.951 )
Diarrhoea: Cycle 3 (n=55,40)	16.36 ( 24.740 )	24.17 ( 25.021 )
Diarrhoea: Cycle 4 (n=50,38)	22.00 ( 27.446 )	15.79 ( 21.556 )
Diarrhoea: Cycle 5 (n=47,34)	22.70 ( 26.105 )	21.57 ( 23.039 )
Diarrhoea: Cycle 6 (n=43,31)	24.03 ( 29.390 )	22.58 ( 21.751 )
Diarrhoea: Cycle 7 (n=39,29)	29.06 ( 27.762 )	25.29 ( 29.080 )
Diarrhoea: Cycle 8 (n=37,25)	26.13 ( 27.369 )	20.00 ( 28.868 )
Diarrhoea: Cycle 9 (n=35,26)	30.48 ( 30.648 )	29.49 ( 33.102 )
Diarrhoea: Cycle 10 (n=35,23)	24.76 ( 26.000 )	27.54 ( 29.563 )
Diarrhoea: Cycle 11 (n=35,24)	23.81 ( 25.012 )	23.61 ( 23.008 )
Diarrhoea: Cycle 12 (n=35,22)	21.90 ( 22.785 )	18.18 ( 22.366 )
Diarrhoea: Cycle 13 (n=34,21)	21.57 ( 21.528 )	19.05 ( 27.021 )
Diarrhoea: Cycle 14 (n=31,19)	23.66 ( 23.084 )	19.30 ( 20.233 )
Diarrhoea: Cycle 15 (n=30,17)	21.11 ( 23.947 )	25.49 ( 22.140 )
Diarrhoea: Cycle 16 (n=27,16)	18.52 ( 25.036 )	20.83 ( 20.638 )
Diarrhoea: Cycle 17 (n=22,15)	21.21 ( 19.370 )	15.56 ( 24.774 )
Diarrhoea: Cycle 18 (n=17,14)	25.49 ( 27.712 )	19.05 ( 25.198 )
Diarrhoea: Cycle 19 (n=12,14)	13.89 ( 17.164 )	19.05 ( 21.540 )
Diarrhoea: Cycle 20 (n=11,13)	27.27 ( 20.101 )	23.08 ( 25.036 )
Diarrhoea: Cycle 21 (n=11,12)	33.33 ( 29.814 )	25.00 ( 28.868 )
Diarrhoea: Cycle 22 (n=11,11)	18.18 ( 31.140 )	21.21 ( 26.968 )
Diarrhoea: Cycle 23 (n=11,10)	24.24 ( 33.635 )	26.67 ( 30.631 )
Diarrhoea: Cycle 24 (n=10,10)	23.33 ( 22.498 )	23.33 ( 31.623 )
Diarrhoea: Cycle 25 (n=10,8)	16.67 ( 17.568 )	29.17 ( 27.817 )
Diarrhoea: Cycle 26 (n=7,7)	19.05 ( 26.227 )	28.57 ( 29.991 )
Diarrhoea: Cycle 27 (n=6,8)	22.22 ( 17.213 )	37.50 ( 33.034 )
Diarrhoea: Cycle 28 (n=7,8)	14.29 ( 17.817 )	29.17 ( 27.817 )
Diarrhoea: Cycle 29 (n=5,7)	0.00 ( 0.000 )	28.57 ( 29.991 )
Diarrhoea: Cycle 30 (n=4,7)	0.00 ( 0.000 )	38.10 ( 23.002 )
Diarrhoea: Cycle 31 (n=2,7)	0.00 ( 0.000 )	33.33 ( 27.217 )
Diarrhoea: Cycle 32 (n=3,6)	22.22 ( 19.245 )	50.00 ( 27.889 )
Diarrhoea: Cycle 33 (n=3,6)	11.11 ( 19.245 )	50.00 ( 27.889 )
Diarrhoea: Cycle 34 (n=3,6)	33.33 ( 33.333 )	44.44 ( 27.217 )
Diarrhoea: Cycle 35 (n=2,6)	16.67 ( 23.570 )	38.89 ( 32.773 )
Diarrhoea: Cycle 36 (n=1,5)	0.00 ( 99999 )	40.00 ( 43.461 )
Diarrhoea: Cycle 37 (n=1,4)	0.00 ( 99999 )	25.00 ( 31.914 )
Diarrhoea: Cycle 38 (n=0,4)	99999 ( 99999 )	41.67 ( 31.914 )
Diarrhoea: Cycle 39 (n=1,3)	0.00 ( 99999 )	33.33 ( 33.333 )
Diarrhoea: Cycle 40 (n=1,3)	0.00 ( 99999 )	44.44 ( 38.490 )
Diarrhoea: Cycle 41 (n=0,3)	99999 ( 99999 )	44.44 ( 38.490 )
Diarrhoea: Cycle 42 (n=0,2)	99999 ( 99999 )	50.00 ( 23.570 )
Diarrhoea: Cycle 43 (n=0,1)	99999 ( 99999 )	66.67 ( 99999 )
Diarrhoea: EOT (n=33,30)	24.24 ( 29.194 )	17.78 ( 24.343 )
Financial Difficulties: Cycle 1 (n=61,43)	25.68 ( 35.691 )	31.01 ( 33.646 )
Financial Difficulties: Cycle 2 (n=57,41)	23.39 ( 28.843 )	21.95 ( 26.468 )
Financial Difficulties: Cycle 3 (n=55,40)	23.03 ( 30.002 )	30.00 ( 34.427 )
Financial Difficulties: Cycle 4 (n=50,38)	24.00 ( 30.147 )	28.95 ( 27.037 )
Financial Difficulties: Cycle 5 (n=47,34)	26.24 ( 34.005 )	25.49 ( 29.654 )
Financial Difficulties: Cycle 6 (n=43,31)	27.13 ( 35.078 )	26.88 ( 31.528 )
Financial Difficulties: Cycle 7 (n=39,29)	29.06 ( 31.696 )	27.59 ( 32.206 )
Financial Difficulties: Cycle 8 (n=37,25)	30.63 ( 32.753 )	25.33 ( 29.313 )
Financial Difficulties: Cycle 9 (n=35,26)	22.86 ( 28.892 )	20.51 ( 29.929 )
Financial Difficulties: Cycle 10 (n=35,23)	25.71 ( 28.105 )	24.64 ( 30.513 )
Financial Difficulties: Cycle 11 (n=35,24)	26.67 ( 27.771 )	23.61 ( 28.622 )
Financial Difficulties: Cycle 12 (n=35,22)	26.67 ( 30.033 )	19.70 ( 26.546 )
Financial Difficulties: Cycle 13 (n=34,21)	23.53 ( 27.864 )	19.05 ( 30.861 )
Financial Difficulties: Cycle 14 (n=31,19)	23.66 ( 28.795 )	17.54 ( 28.040 )
Financial Difficulties: Cycle 15 (n=30,17)	21.11 ( 22.289 )	19.61 ( 29.009 )
Financial Difficulties: Cycle 16 (n=27,16)	22.22 ( 22.646 )	18.75 ( 29.736 )
Financial Difficulties: Cycle 17 (n=22,15)	19.70 ( 24.471 )	15.56 ( 27.794 )
Financial Difficulties: Cycle 18 (n=17,14)	17.65 ( 29.149 )	16.67 ( 21.681 )
Financial Difficulties: Cycle 19 (n=12,14)	22.22 ( 32.824 )	14.29 ( 17.118 )
Financial Difficulties: Cycle 20 (n=11,13)	15.15 ( 22.918 )	15.38 ( 29.235 )
Financial Difficulties: Cycle 21 (n=11, 12)	24.24 ( 33.635 )	16.67 ( 30.151 )
Financial Difficulties: Cycle 22 (n=11, 11)	18.18 ( 27.340 )	15.15 ( 22.918 )
Financial Difficulties: Cycle 23 (n=11, 10)	15.15 ( 22.918 )	20.00 ( 32.203 )
Financial Difficulties: Cycle 24 (n=10, 10)	20.00 ( 28.109 )	16.67 ( 32.394 )
Financial Difficulties: Cycle 25 (n=10, 8)	16.67 ( 28.328 )	29.17 ( 37.533 )
Financial Difficulties: Cycle 26 (n=7, 7)	23.81 ( 31.706 )	28.57 ( 40.500 )
Financial Difficulties: Cycle 27 (n=6, 8)	16.67 ( 27.889 )	20.83 ( 35.355 )
Financial Difficulties: Cycle 28 (n=7, 8)	19.05 ( 26.227 )	20.83 ( 35.355 )
Financial Difficulties: Cycle 29 (n=5, 7)	13.33 ( 29.814 )	19.05 ( 37.796 )
Financial Difficulties: Cycle 30 (n=4, 7)	16.67 ( 33.333 )	19.05 ( 37.796 )
Financial Difficulties: Cycle 31 (n=2, 7)	33.33 ( 47.140 )	19.05 ( 37.796 )
Financial Difficulties: Cycle 32 (n=3, 6)	22.22 ( 38.490 )	22.22 ( 40.369 )
Financial Difficulties: Cycle 33 (n=3, 6)	33.33 ( 33.333 )	22.22 ( 40.369 )
Financial Difficulties: Cycle 34 (n=3, 6)	22.22 ( 19.245 )	22.22 ( 40.369 )
Financial Difficulties: Cycle 35 (n=2, 6)	50.00 ( 23.570 )	22.22 ( 40.369 )
Financial Difficulties: Cycle 36 (n=1, 5)	0.00 ( 99999 )	20.00 ( 44.721 )
Financial Difficulties: Cycle 37 (n=1, 4)	33.33 ( 99999 )	8.33 ( 16.667 )
Financial Difficulties: Cycle 38 (n=0, 4)A	99999 ( 99999 )	8.33 ( 16.667 )
Financial Difficulties: Cycle 39 (n=1, 3)	0.00 ( 99999 )	11.11 ( 19.245 )
Financial Difficulties: Cycle 40 (n=1, 3)	33.33 ( 99999 )	11.11 ( 19.245 )
Financial Difficulties: Cycle 41 (n=0, 3)	99999 ( 99999 )	22.22 ( 19.245 )
Financial Difficulties: Cycle 42 (n=0, 2)	99999 ( 99999 )	0.00 ( 0.000 )
Financial Difficulties: Cycle 43 (n=0, 1)	99999 ( 99999 )	0.00 ( 99999 )
Financial Difficulties: EOT (n=33, 30)	30.30 ( 29.302 )	23.33 ( 26.479 )

No statistical analyses for this end point

Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)

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End point title

Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)

End point description

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. Here, "99999" for mean and standard deviation signifies data not available (NA) as none of the subjects were evaluable in the given group at this time point. FAS population and 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.

End point type

Secondary

End point timeframe

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: units on a scale
arithmetic mean (standard deviation)
Endocrine Symptoms: Cycle 1 (n=61,44)	9.47 ( 14.746 )	15.66 ( 20.378 )
Endocrine Symptoms: Cycle 2 (n=57,41)	9.94 ( 14.347 )	14.91 ( 16.407 )
Endocrine Symptoms: Cycle 3 (n=55,40)	14.75 ( 20.066 )	11.67 ( 14.443 )
Endocrine Symptoms: Cycle 4 (n=50,37)	12.67 ( 15.227 )	12.31 ( 14.531 )
Endocrine Symptoms: Cycle 5 (n=47,33)	12.29 ( 13.752 )	8.08 ( 12.507 )
Endocrine Symptoms: Cycle 6 (n=43,31)	13.18 ( 16.490 )	9.32 ( 13.788 )
Endocrine Symptoms: Cycle 7 (n=39,29)	12.82 ( 14.315 )	12.07 ( 16.538 )
Endocrine Symptoms: Cycle 8 (n=37,25)	13.81 ( 18.408 )	10.67 ( 14.515 )
Endocrine Symptoms: Cycle 9 (n=35,26)	10.16 ( 14.851 )	11.11 ( 14.741 )
Endocrine Symptoms: Cycle 10 (n=35,23)	10.16 ( 13.304 )	14.01 ( 18.416 )
Endocrine Symptoms: Cycle 11 (n=35,24)	13.02 ( 16.934 )	13.43 ( 19.653 )
Endocrine Symptoms: Cycle 12 (n=35,22)	12.06 ( 16.693 )	11.62 ( 17.644 )
Endocrine Symptoms: Cycle 13 (n=34,21)	10.46 ( 14.459 )	11.64 ( 15.899 )
Endocrine Symptoms: Cycle 14 (n=31,19)	12.19 ( 16.815 )	14.62 ( 18.538 )
Endocrine Symptoms: Cycle 15 (n=30,17)	13.33 ( 18.082 )	15.69 ( 18.864 )
Endocrine Symptoms: Cycle 16 (n=27,16)	10.70 ( 16.155 )	9.03 ( 11.631 )
Endocrine Symptoms: Cycle 17 (n=22,15)	12.12 ( 18.753 )	8.89 ( 10.457 )
Endocrine Symptoms: Cycle 18 (n=17,14)	11.11 ( 18.840 )	11.90 ( 14.756 )
Endocrine Symptoms: Cycle 19 (n=12,14)	14.81 ( 21.364 )	6.35 ( 11.293 )
Endocrine Symptoms: Cycle 20 (n=11,13)	15.15 ( 20.045 )	11.11 ( 17.568 )
Endocrine Symptoms: Cycle 21 (n=11,12)	20.20 ( 20.975 )	9.26 ( 12.385 )
Endocrine Symptoms: Cycle 22 (n=11,11)	14.14 ( 19.303 )	16.16 ( 21.294 )
Endocrine Symptoms: Cycle 23 (n=11,10)	18.18 ( 15.131 )	13.33 ( 16.397 )
Endocrine Symptoms: Cycle 24 (n=10,10)	22.22 ( 31.427 )	13.33 ( 14.628 )
Endocrine Symptoms: Cycle 25 (n=10,8)	16.67 ( 23.570 )	8.33 ( 12.944 )
Endocrine Symptoms: Cycle 26 (n=7,7)	22.22 ( 27.962 )	7.94 ( 13.929 )
Endocrine Symptoms: Cycle 27 (n=6,8)	22.22 ( 28.109 )	9.72 ( 12.511 )
Endocrine Symptoms: Cycle 28 (n=7,8)	19.05 ( 29.197 )	12.50 ( 18.245 )
Endocrine Symptoms: Cycle 29 (n=6,7)	12.96 ( 12.989 )	11.11 ( 12.830 )
Endocrine Symptoms: Cycle 30 (n=5,7)	8.89 ( 9.296 )	14.29 ( 13.929 )
Endocrine Symptoms: Cycle 31 (n=3,7)	14.81 ( 6.415 )	12.70 ( 11.878 )
Endocrine Symptoms: Cycle 32 (n=3,6)	7.41 ( 12.830 )	14.81 ( 13.456 )
Endocrine Symptoms: Cycle 33 (n=3,6)	11.11 ( 0.000 )	16.67 ( 11.653 )
Endocrine Symptoms: Cycle 34 (n=3,6)	18.52 ( 6.415 )	20.37 ( 23.744 )
Endocrine Symptoms: Cycle 35 (n=2,6)	22.22 ( 0.000 )	16.67 ( 16.851 )
Endocrine Symptoms: Cycle 36 (n=1,5)	22.22 ( 99999 )	17.78 ( 18.592 )
Endocrine Symptoms: Cycle 37 (n=1,4)	22.22 ( 99999 )	5.56 ( 11.111 )
Endocrine Symptoms: Cycle 38 (n=0,4)	99999 ( 99999 )	8.33 ( 10.638 )
Endocrine Symptoms: Cycle 39 (n=1,3)	22.22 ( 99999 )	11.11 ( 11.111 )
Endocrine Symptoms: Cycle 40 (n=1,3)	22.22 ( 99999 )	11.11 ( 11.111 )
Endocrine Symptoms: Cycle 41 (n=0,3)	99999 ( 99999 )	11.11 ( 11.111 )
Endocrine Symptoms: Cycle 42 (n=0,2)	99999 ( 99999 )	0.00 ( 0.000 )
Endocrine Symptoms: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Endocrine Symptoms: EOT (n=33,29)	13.80 ( 15.474 )	11.11 ( 16.534 )
Gastrointestinal Symptoms: Cycle 1 (n=61,44)	15.41 ( 14.633 )	15.30 ( 13.301 )
Gastrointestinal Symptoms: Cycle 2 (n=57,41)	17.66 ( 14.057 )	17.72 ( 13.631 )
Gastrointestinal Symptoms: Cycle 3 (n=55,40)	20.24 ( 17.543 )	19.50 ( 16.702 )
Gastrointestinal Symptoms: Cycle 4 (n=50,38)	19.47 ( 16.814 )	19.30 ( 17.315 )
Gastrointestinal Symptoms: Cycle 5 (n=47,33)	15.18 ( 13.528 )	21.01 ( 17.569 )
Gastrointestinal Symptoms: Cycle 6 (n=43,31)	18.76 ( 16.982 )	21.51 ( 20.273 )
Gastrointestinal Symptoms: Cycle 7 (n=39,29)	18.63 ( 19.114 )	20.23 ( 18.728 )
Gastrointestinal Symptoms: Cycle 8 (n=37,25)	20.72 ( 19.359 )	19.47 ( 15.743 )
Gastrointestinal Symptoms: Cycle 9 (n=35,26)	18.86 ( 18.040 )	19.49 ( 17.681 )
Gastrointestinal Symptoms: Cycle 10 (n=35,23)	18.38 ( 17.916 )	19.78 ( 18.315 )
Gastrointestinal Symptoms: Cycle 11 (n=35,24)	18.86 ( 15.295 )	16.94 ( 17.360 )
Gastrointestinal Symptoms: Cycle 12 (n=35,22)	18.86 ( 18.040 )	18.79 ( 20.741 )
Gastrointestinal Symptoms: Cycle 13 (n=34,21)	18.04 ( 17.641 )	14.60 ( 13.600 )
Gastrointestinal Symptoms: Cycle 14 (n=31,19)	18.06 ( 18.871 )	16.49 ( 13.943 )
Gastrointestinal Symptoms: Cycle 15 (n=30,17)	19.56 ( 17.934 )	22.35 ( 22.966 )
Gastrointestinal Symptoms: Cycle 16 (n=27,16)	17.53 ( 17.458 )	17.50 ( 14.782 )
Gastrointestinal Symptoms: Cycle 17 (n=22,15)	18.18 ( 19.099 )	13.78 ( 12.206 )
Gastrointestinal Symptoms: Cycle 18 (n=17,14)	24.31 ( 20.942 )	15.71 ( 12.433 )
Gastrointestinal Symptoms: Cycle 19 (n=12,14)	23.89 ( 21.360 )	20.48 ( 20.500 )
Gastrointestinal Symptoms: Cycle 20 (n=11,13)	25.45 ( 22.473 )	16.41 ( 15.303 )
Gastrointestinal Symptoms: Cycle 21 (n=11,12)	29.09 ( 22.759 )	17.22 ( 16.927 )
Gastrointestinal Symptoms: Cycle 22 (n=11,11)	23.03 ( 21.574 )	18.18 ( 18.641 )
Gastrointestinal Symptoms: Cycle 23 (n=11,10)	27.27 ( 26.408 )	20.00 ( 18.856 )
Gastrointestinal Symptoms: Cycle 24 (n=10,10)	26.00 ( 20.476 )	21.33 ( 18.539 )
Gastrointestinal Symptoms: Cycle 25 (n=10,8)	24.67 ( 19.386 )	23.33 ( 17.090 )
Gastrointestinal Symptoms: Cycle 26 (n=7,7)	30.48 ( 17.152 )	20.95 ( 15.601 )
Gastrointestinal Symptoms: Cycle 27 (n=6,8)	34.44 ( 28.415 )	25.83 ( 20.912 )
Gastrointestinal Symptoms: Cycle 28 (n=7,8)	28.57 ( 23.637 )	23.96 ( 20.967 )
Gastrointestinal Symptoms: Cycle 29 (n=6,7)	22.22 ( 5.443 )	28.57 ( 17.090 )
Gastrointestinal Symptoms: Cycle 30 (n=5,7)	18.67 ( 15.202 )	21.90 ( 17.518 )
Gastrointestinal Symptoms: Cycle 31 (n=3,7)	24.44 ( 26.943 )	22.86 ( 19.572 )
Gastrointestinal Symptoms: Cycle 32 (n=3,6)	22.22 ( 27.756 )	27.78 ( 19.052 )
Gastrointestinal Symptoms: Cycle 33 (n=3,6)	26.67 ( 35.277 )	23.33 ( 17.256 )
Gastrointestinal Symptoms: Cycle 34 (n=3,6)	20.00 ( 29.059 )	28.89 ( 15.587 )
Gastrointestinal Symptoms: Cycle 35 (n=2,6)	23.33 ( 32.998 )	20.00 ( 15.202 )
Gastrointestinal Symptoms: Cycle 36 (n=1,5)	0.00 ( 99999 )	17.33 ( 15.348 )
Gastrointestinal Symptoms: Cycle 37 (n=1,4)	0.00 ( 99999 )	21.67 ( 13.744 )
Gastrointestinal Symptoms: Cycle 38 (n=0,4)	99999 ( 99999 )	27.92 ( 20.520 )
Gastrointestinal Symptoms: Cycle 39 (n=1,3)	6.67 ( 99999 )	31.11 ( 19.245 )
Gastrointestinal Symptoms: Cycle 40 (n=1,3)	0.00 ( 99999 )	26.67 ( 17.638 )
Gastrointestinal Symptoms: Cycle 41 (n=0,3)	99999 ( 99999 )	35.56 ( 21.430 )
Gastrointestinal Symptoms: Cycle 42 (n=0,2)	99999 ( 99999 )	33.33 ( 18.856 )
Gastrointestinal Symptoms: Cycle 43 (n=0,1)	99999 ( 99999 )	20.00 ( 99999 )
Gastrointestinal Symptoms:EOT (n=33,29)	23.23 ( 18.568 )	18.85 ( 19.766 )
Treatment Related Symptoms: Cycle 1 (n=19,13)	12.57 ( 14.797 )	16.24 ( 19.038 )
Treatment Related Symptoms: Cycle 2 (n=56,36)	14.48 ( 11.686 )	16.20 ( 14.141 )
Treatment Related Symptoms: Cycle 3 (n=49,39)	15.42 ( 12.280 )	17.09 ( 18.574 )
Treatment Related Symptoms: Cycle 4 (n=45,36)	17.53 ( 15.622 )	13.89 ( 16.074 )
Treatment Related Symptoms: Cycle 5 (n=45,31)	15.06 ( 11.522 )	14.52 ( 15.361 )
Treatment Related Symptoms: Cycle 6 (n=41,30)	15.45 ( 13.293 )	15.00 ( 17.577 )
Treatment Related Symptoms: Cycle 7 (n=37,27)	18.77 ( 16.216 )	15.84 ( 17.207 )
Treatment Related Symptoms: Cycle 8 (n=35,24)	20.48 ( 19.930 )	14.12 ( 17.870 )
Treatment Related Symptoms: Cycle 9 (n=32,23)	18.23 ( 15.917 )	14.01 ( 17.558 )
Treatment Related Symptoms: Cycle 10 (n=33,23)	15.99 ( 15.760 )	16.91 ( 17.446 )
Treatment Related Symptoms: Cycle 11 (n=35,24)	16.83 ( 16.196 )	15.05 ( 21.453 )
Treatment Related Symptoms: Cycle 12 (n=34,21)	16.01 ( 18.989 )	11.11 ( 13.494 )
Treatment Related Symptoms: Cycle 13 (n=32,19)	15.45 ( 12.441 )	7.89 ( 8.942 )
Treatment Related Symptoms: Cycle 14 (n=29,19)	13.60 ( 12.386 )	11.70 ( 13.968 )
Treatment Related Symptoms: Cycle 15 (n=28,16)	15.48 ( 12.950 )	8.68 ( 12.664 )
Treatment Related Symptoms: Cycle 16 (n=25,15)	13.78 ( 13.714 )	10.74 ( 14.467 )
Treatment Related Symptoms: Cycle 17 (n=21,15)	14.81 ( 15.941 )	7.41 ( 8.572 )
Treatment Related Symptoms: Cycle 18 (n=16,14)	17.71 ( 16.999 )	10.71 ( 11.828 )
Treatment Related Symptoms: Cycle 19 (n=10,14)	20.00 ( 17.013 )	12.30 ( 13.287 )
Treatment Related Symptoms: Cycle 20 (n=10,12)	18.33 ( 17.382 )	9.72 ( 11.392 )
Treatment Related Symptoms: Cycle 21 (n=11,12)	18.18 ( 18.608 )	14.81 ( 14.279 )
Treatment Related Symptoms: Cycle 22 (n=10,11)	24.44 ( 22.253 )	12.63 ( 12.691 )
Treatment Related Symptoms: Cycle 23 (n=10,10)	22.22 ( 23.570 )	13.89 ( 13.671 )
Treatment Related Symptoms: Cycle 24 (n=9,10)	22.84 ( 24.602 )	11.67 ( 13.969 )
Treatment Related Symptoms: Cycle 25 (n=8,8)	21.53 ( 21.504 )	15.28 ( 14.164 )
Treatment Related Symptoms: Cycle 26 (n=7,7)	26.19 ( 21.448 )	12.70 ( 11.437 )
Treatment Related Symptoms: Cycle 27 (n=6,8)	37.96 ( 16.636 )	19.44 ( 18.306 )
Treatment Related Symptoms: Cycle 28 (n=5,8)	35.56 ( 21.009 )	17.36 ( 15.555 )
Treatment Related Symptoms: Cycle 29 (n=4,7)	16.67 ( 4.536 )	15.87 ( 12.184 )
Treatment Related Symptoms: Cycle 30 (n=3,7)	20.37 ( 3.208 )	15.87 ( 14.138 )
Treatment Related Symptoms: Cycle 31 (n=3,7)	22.22 ( 11.111 )	20.63 ( 17.484 )
Treatment Related Symptoms: Cycle 32 (n=3,6)	16.67 ( 5.556 )	20.37 ( 7.590 )
Treatment Related Symptoms: Cycle 33 (n=3,6)	22.22 ( 11.111 )	20.37 ( 7.590 )
Treatment Related Symptoms: Cycle 34 (n=3,6)	27.78 ( 9.623 )	20.37 ( 12.989 )
Treatment Related Symptoms: Cycle 35 (n=2,6)	11.11 ( 15.713 )	17.59 ( 11.340 )
Treatment Related Symptoms: Cycle 36 (n=1,5)	16.67 ( 99999 )	25.56 ( 7.454 )
Treatment Related Symptoms: Cycle 37 (n=1,4)	16.67 ( 99999 )	26.39 ( 8.333 )
Treatment Related Symptoms: Cycle 38 (n=0,3)	99999 ( 99999 )	22.22 ( 11.111 )
Treatment Related Symptoms: Cycle 39 (n=1,3)	0.00 ( 99999 )	29.63 ( 6.415 )
Treatment Related Symptoms: Cycle 40 (n=1,3)	0.00 ( 99999 )	25.93 ( 6.415 )
Treatment Related Symptoms: Cycle 41 (n=0,3)	99999 ( 99999 )	24.07 ( 8.486 )
Treatment Related Symptoms: Cycle 42 (n=0,2)	99999 ( 99999 )	27.78 ( 7.857 )
Treatment Related Symptoms: Cycle 43 (n=0,1)	99999 ( 99999 )	33.33 ( 99999 )
Treatment Related Symptoms: EOT (n=29,27)	24.33 ( 20.542 )	20.78 ( 24.969 )
Social Functioning: Cycle 1 (n=61,44)	35.34 ( 22.907 )	31.06 ( 20.132 )
Social Functioning: Cycle 2 (n=57,41)	30.99 ( 21.490 )	29.81 ( 22.695 )
Social Functioning: Cycle 3 (n=55,40)	29.49 ( 20.534 )	30.00 ( 25.061 )
Social Functioning: Cycle 4 (n=50,38)	27.00 ( 19.441 )	26.17 ( 22.331 )
Social Functioning: Cycle 5 (n=47,33)	27.90 ( 19.087 )	24.24 ( 22.473 )
Social Functioning: Cycle 6 (n=43,31)	25.71 ( 21.138 )	28.32 ( 23.101 )
Social Functioning: Cycle 7 (n=39,29)	29.06 ( 20.171 )	27.20 ( 26.157 )
Social Functioning: Cycle 8 (n=37,25)	30.63 ( 20.015 )	27.11 ( 20.051 )
Social Functioning: Cycle 9 (n=35,26)	29.84 ( 27.715 )	23.08 ( 19.607 )
Social Functioning: Cycle 10 (n=35,23)	28.89 ( 22.579 )	24.64 ( 24.835 )
Social Functioning: Cycle 11 (n=35,24)	29.21 ( 21.573 )	24.07 ( 22.383 )
Social Functioning: Cycle 12 (n=35,22)	28.25 ( 24.454 )	23.74 ( 22.562 )
Social Functioning: Cycle 13 (n=34,21)	24.84 ( 23.380 )	23.81 ( 23.382 )
Social Functioning: Cycle 14 (n=31,19)	27.96 ( 20.056 )	25.73 ( 24.018 )
Social Functioning: Cycle 15 (n=30,17)	28.52 ( 20.149 )	28.76 ( 28.070 )
Social Functioning: Cycle 16 (n=27,16)	27.16 ( 20.286 )	27.78 ( 23.307 )
Social Functioning: Cycle 17 (n=22,15)	28.79 ( 21.320 )	23.70 ( 22.564 )
Social Functioning: Cycle 18 (n=17,14)	29.41 ( 26.040 )	26.98 ( 21.666 )
Social Functioning: Cycle 19 (n=12,14)	29.63 ( 25.219 )	28.57 ( 22.943 )
Social Functioning: Cycle 20 (n=11,13)	31.82 ( 28.119 )	29.06 ( 28.160 )
Social Functioning: Cycle 21 (n=11,12)	35.35 ( 30.151 )	24.07 ( 23.130 )
Social Functioning: Cycle 22 (n=11,11)	31.31 ( 28.029 )	27.27 ( 24.527 )
Social Functioning: Cycle 23 (n=11,10)	30.30 ( 28.149 )	26.67 ( 27.317 )
Social Functioning: Cycle 24 (n=10,10)	38.89 ( 28.328 )	24.44 ( 24.456 )
Social Functioning: Cycle 25 (n=10,8)	35.56 ( 27.116 )	31.94 ( 26.184 )
Social Functioning: Cycle 26 (n=7,7)	46.03 ( 28.276 )	22.22 ( 11.111 )
Social Functioning: Cycle 27 (n=6,8)	51.85 ( 28.689 )	33.33 ( 28.483 )
Social Functioning: Cycle 28 (n=7,8)	46.03 ( 33.597 )	31.94 ( 29.360 )
Social Functioning: Cycle 29 (n=6,7)	35.19 ( 25.740 )	28.57 ( 27.857 )
Social Functioning: Cycle 30 (n=5,7)	35.56 ( 26.527 )	30.16 ( 29.893 )
Social Functioning: Cycle 31 (n=3,7)	44.44 ( 22.222 )	30.16 ( 29.197 )
Social Functioning: Cycle 32 (n=3,6)	33.33 ( 11.111 )	31.48 ( 30.965 )
Social Functioning: Cycle 33 (n=3,6)	40.74 ( 23.130 )	40.74 ( 31.164 )
Social Functioning: Cycle 34 (n=3,6)	44.44 ( 22.222 )	35.19 ( 29.327 )
Social Functioning: Cycle 35 (n=2,6)	38.89 ( 23.570 )	33.33 ( 24.343 )
Social Functioning: Cycle 36 (n=1,5)	22.22 ( 99999 )	31.11 ( 27.666 )
Social Functioning: Cycle 37 (n=1,4)	22.22 ( 99999 )	30.56 ( 39.933 )
Social Functioning: Cycle 38 (n=0,4)	99999 ( 99999 )	41.67 ( 41.944 )
Social Functioning: Cycle 39 (n=1,3)	33.33 ( 99999 )	51.85 ( 44.905 )
Social Functioning: Cycle 40 (n=1,3)	11.11 ( 99999 )	42.59 ( 36.991 )
Social Functioning: Cycle 41 (n=0,3)	99999 ( 99999 )	44.44 ( 40.062 )
Social Functioning: Cycle 42 (n=0,2)	99999 ( 99999 )	38.89 ( 39.284 )
Social Functioning: Cycle 43 (n=0,1)	99999 ( 99999 )	11.11 ( 99999 )
Social Functioning: EOT (n=33,29)	39.73 ( 25.914 )	41.38 ( 26.874 )
Disease Related Worries: Cycle 1 (n=61,43)	49.27 ( 26.381 )	42.89 ( 23.108 )
Disease Related Worries: Cycle 2 (n=57,41)	38.01 ( 24.550 )	36.04 ( 24.942 )
Disease Related Worries: Cycle 3 (n=55,40)	36.46 ( 23.074 )	34.58 ( 23.853 )
Disease Related Worries: Cycle 4 (n=50,38)	31.89 ( 22.075 )	33.19 ( 23.904 )
Disease Related Worries: Cycle 5 (n=47,33)	37.12 ( 25.619 )	30.64 ( 22.742 )
Disease Related Worries: Cycle 6 (n=43,31)	36.43 ( 25.148 )	34.05 ( 25.000 )
Disease Related Worries: Cycle 7 (n=39,29)	39.32 ( 24.825 )	32.18 ( 26.618 )
Disease Related Worries: Cycle 8 (n=37,25)	38.29 ( 25.653 )	32.00 ( 22.753 )
Disease Related Worries: Cycle 9 (n=35,26)	35.71 ( 31.116 )	32.05 ( 22.072 )
Disease Related Worries: Cycle 10 (n=35,23)	37.30 ( 26.458 )	28.02 ( 26.563 )
Disease Related Worries: Cycle 11 (n=35,24)	35.87 ( 25.292 )	27.78 ( 22.700 )
Disease Related Worries: Cycle 12 (n=35,22)	35.56 ( 28.621 )	29.29 ( 25.325 )
Disease Related Worries: Cycle 13 (n=34,21)	34.64 ( 27.046 )	30.16 ( 24.881 )
Disease Related Worries: Cycle 14 (n=31,19)	32.97 ( 22.312 )	31.87 ( 22.055 )
Disease Related Worries: Cycle 15 (n=30,17)	34.44 ( 25.160 )	33.66 ( 27.250 )
Disease Related Worries: Cycle 16 (n=27,16)	34.16 ( 25.022 )	37.85 ( 23.589 )
Disease Related Worries: Cycle 17 (n=22,15)	29.80 ( 22.059 )	34.07 ( 27.043 )
Disease Related Worries: Cycle 18 (n=17,14)	30.07 ( 28.805 )	32.14 ( 27.232 )
Disease Related Worries: Cycle 19 (n=12,14)	37.50 ( 29.504 )	31.75 ( 28.862 )
Disease Related Worries: Cycle 20 (n=11,13)	40.40 ( 32.687 )	29.91 ( 31.877 )
Disease Related Worries: Cycle 21 (n=11,12)	39.90 ( 30.512 )	27.78 ( 30.887 )
Disease Related Worries: Cycle 22 (n=11,11)	33.33 ( 31.032 )	30.30 ( 34.816 )
Disease Related Worries: Cycle 23 (n=11,10)	36.36 ( 35.168 )	26.11 ( 29.403 )
Disease Related Worries: Cycle 24 (n=10,10)	41.11 ( 32.309 )	27.78 ( 28.328 )
Disease Related Worries: Cycle 25 (n=10,8)	38.33 ( 32.547 )	38.89 ( 31.983 )
Disease Related Worries: Cycle 26 (n=7,7)	42.86 ( 33.597 )	31.75 ( 33.597 )
Disease Related Worries: Cycle 27 (n=6,8)	52.78 ( 40.023 )	34.72 ( 28.133 )
Disease Related Worries: Cycle 28 (n=7,8)	50.79 ( 38.946 )	40.28 ( 39.368 )
Disease Related Worries: Cycle 29 (n=6,7)	37.96 ( 35.210 )	38.10 ( 35.635 )
Disease Related Worries: Cycle 30 (n=5,7)	35.56 ( 38.809 )	34.92 ( 29.696 )
Disease Related Worries: Cycle 31 (n=3,7)	48.15 ( 46.259 )	36.51 ( 32.530 )
Disease Related Worries: Cycle 32 (n=3,6)	25.93 ( 23.130 )	37.04 ( 38.276 )
Disease Related Worries: Cycle 33 (n=3,6)	51.85 ( 42.066 )	35.19 ( 36.118 )
Disease Related Worries: Cycle 34 (n=3,6)	55.56 ( 40.062 )	35.19 ( 36.796 )
Disease Related Worries: Cycle 35 (n=2,6)	16.67 ( 23.570 )	35.19 ( 34.006 )
Disease Related Worries: Cycle 36 (n=1,5)	0.00 ( 99999 )	31.11 ( 36.345 )
Disease Related Worries: Cycle 37 (n=1,4)	0.00 ( 99999 )	22.22 ( 31.427 )
Disease Related Worries: Cycle 38 (n=0,4)	99999 ( 99999 )	33.33 ( 45.361 )
Disease Related Worries: Cycle 39 (n=1,3)	0.00 ( 99999 )	44.44 ( 50.918 )
Disease Related Worries: Cycle 40 (n=1,3)	0.00 ( 99999 )	37.04 ( 35.717 )
Disease Related Worries: Cycle 41 (n=0,3)	99999 ( 99999 )	44.44 ( 50.918 )
Disease Related Worries: Cycle 42 (n=0,2)	99999 ( 99999 )	50.00 ( 54.997 )
Disease Related Worries: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Disease Related Worries: EOT (n=33,29)	50.84 ( 27.079 )	41.38 ( 30.123 )
Muscle/Bone Pain Symptom: Cycle 1 (n=59,44)	13.56 ( 20.640 )	13.64 ( 20.734 )
Muscle/Bone Pain Symptom: Cycle 2 (n=57,41)	20.47 ( 24.197 )	17.89 ( 23.685 )
Muscle/Bone Pain Symptom: Cycle 3 (n=55,40)	16.36 ( 19.108 )	23.33 ( 24.108 )
Muscle/Bone Pain Symptom: Cycle 4 (n=50,38)	16.00 ( 20.471 )	21.93 ( 26.024 )
Muscle/Bone Pain Symptom: Cycle 5 (n=47,33)	17.02 ( 18.221 )	22.22 ( 27.217 )
Muscle/Bone Pain Symptom: Cycle 6 (n=43,31)	18.60 ( 20.959 )	20.43 ( 23.847 )
Muscle/Bone Pain Symptom: Cycle 7 (n=39,29)	20.51 ( 22.446 )	21.84 ( 29.915 )
Muscle/Bone Pain Symptom: Cycle 8 (n=37,25)	20.72 ( 22.705 )	20.00 ( 23.570 )
Muscle/Bone Pain Symptom: Cycle 9 (n=35,26)	16.19 ( 18.737 )	20.51 ( 21.243 )
Muscle/Bone Pain Symptom: Cycle 10 (n=35,23)	20.00 ( 25.820 )	24.64 ( 28.810 )
Muscle/Bone Pain Symptom: Cycle 11 (n=35,24)	21.90 ( 25.492 )	22.22 ( 25.380 )
Muscle/Bone Pain Symptom: Cycle 12 (n=35,22)	20.95 ( 26.918 )	19.70 ( 24.471 )
Muscle/Bone Pain Symptom: Cycle 13 (n=34,21)	20.59 ( 24.638 )	23.81 ( 28.172 )
Muscle/Bone Pain Symptom: Cycle 14 (n=31,19)	12.90 ( 22.240 )	22.81 ( 27.336 )
Muscle/Bone Pain Symptom: Cycle 15 (n=29,17)	11.49 ( 18.422 )	25.49 ( 32.338 )
Muscle/Bone Pain Symptom: Cycle 16 (n=27,16)	19.75 ( 24.909 )	16.67 ( 24.343 )
Muscle/Bone Pain Symptom: Cycle 17 (n=22,15)	22.73 ( 25.996 )	15.56 ( 24.774 )
Muscle/Bone Pain Symptom: Cycle 18 (n=17,14)	15.69 ( 20.809 )	14.29 ( 25.198 )
Muscle/Bone Pain Symptom: Cycle 19 (n=12,14)	25.00 ( 20.719 )	16.67 ( 25.318 )
Muscle/Bone Pain Symptom: Cycle 20 (n=11,13)	27.27 ( 25.025 )	12.82 ( 21.681 )
Muscle/Bone Pain Symptom: Cycle 21 (n=11,12)	21.21 ( 22.473 )	13.89 ( 22.285 )
Muscle/Bone Pain Symptom: Cycle 22 (n=11,11)	15.15 ( 22.918 )	24.24 ( 26.208 )
Muscle/Bone Pain Symptom: Cycle 23 (n=11,10)	21.21 ( 26.968 )	23.33 ( 22.498 )
Muscle/Bone Pain Symptom: Cycle 24 (n=10,10)	20.00 ( 23.307 )	30.00 ( 29.187 )
Muscle/Bone Pain Symptom: Cycle 25 (n=10,8)	23.33 ( 27.442 )	33.33 ( 30.861 )
Muscle/Bone Pain Symptom: Cycle 26 (n=7,7)	33.33 ( 27.217 )	28.57 ( 29.991 )
Muscle/Bone Pain Symptom: Cycle 27 (n=6,8)	50.00 ( 18.257 )	29.17 ( 27.817 )
Muscle/Bone Pain Symptom: Cycle 28 (n=7,8)	38.10 ( 23.002 )	33.33 ( 35.635 )
Muscle/Bone Pain Symptom: Cycle 29 (n=6,7)	22.22 ( 27.217 )	33.33 ( 27.217 )
Muscle/Bone Pain Symptom: Cycle 30 (n=5,7)	26.67 ( 27.889 )	28.57 ( 35.635 )
Muscle/Bone Pain Symptom: Cycle 31 (n=3,7)	22.22 ( 38.490 )	38.10 ( 29.991 )
Muscle/Bone Pain Symptom: Cycle 32 (n=3,6)	22.22 ( 38.490 )	38.89 ( 13.608 )
Muscle/Bone Pain Symptom: Cycle 33 (n=3,6)	33.33 ( 33.333 )	33.33 ( 29.814 )
Muscle/Bone Pain Symptom: Cycle 34 (n=3,6)	11.11 ( 19.245 )	44.44 ( 17.213 )
Muscle/Bone Pain Symptom: Cycle 35 (n=2,6)	33.33 ( 47.140 )	38.89 ( 13.608 )
Muscle/Bone Pain Symptom: Cycle 36 (n=1,5)	0.00 ( 99999 )	53.33 ( 18.257 )
Muscle/Bone Pain Symptom: Cycle 37 (n=1,4)	0.00 ( 99999 )	50.00 ( 19.245 )
Muscle/Bone Pain Symptom: Cycle 38 (n=0,4)	99999 ( 99999 )	58.33 ( 16.667 )
Muscle/Bone Pain Symptom: Cycle 39 (n=1,3)	0.00 ( 99999 )	44.44 ( 19.245 )
Muscle/Bone Pain Symptom: Cycle 40 (n=1,3)	33.33 ( 99999 )	55.56 ( 19.245 )
Muscle/Bone Pain Symptom: Cycle 41 (n=0,3)	99999 ( 99999 )	55.56 ( 19.245 )
Muscle/Bone Pain Symptom: Cycle 42 (n=0,2)	99999 ( 99999 )	50.00 ( 23.570 )
Muscle/Bone Pain Symptom: Cycle 43 (n=0,1)	99999 ( 99999 )	66.67 ( 99999 )
Muscle/Bone Pain Symptom: EOT (n=33,29)	25.25 ( 27.677 )	26.44 ( 30.052 )
Sexual Function: Cycle 1 (n=34,29)	22.55 ( 31.485 )	34.48 ( 35.054 )
Sexual Function: Cycle 2 (n=43,30)	17.83 ( 25.561 )	30.00 ( 30.763 )
Sexual Function: Cycle 3 (n=39,29)	17.95 ( 25.185 )	36.78 ( 32.544 )
Sexual Function: Cycle 4 (n=34,27)	18.63 ( 24.878 )	22.22 ( 30.662 )
Sexual Function: Cycle 5 (n=32,27)	18.75 ( 25.312 )	28.40 ( 35.450 )
Sexual Function: Cycle 6 (n=30,23)	14.44 ( 20.869 )	31.88 ( 35.503 )
Sexual Function: Cycle 7 (n=28,23)	19.05 ( 24.727 )	30.43 ( 37.488 )
Sexual Function: Cycle 8 (n=26,16)	23.08 ( 27.919 )	27.08 ( 27.806 )
Sexual Function: Cycle 9 (n=25,19)	13.33 ( 27.217 )	28.07 ( 31.940 )
Sexual Function: Cycle 10 (n=25,16)	17.33 ( 29.059 )	27.08 ( 32.702 )
Sexual Function: Cycle 11 (n=25,16)	16.00 ( 25.676 )	20.83 ( 26.874 )
Sexual Function: Cycle 12 (n=26,14)	20.51 ( 29.929 )	19.05 ( 25.198 )
Sexual Function: Cycle 13 (n=24,15)	16.67 ( 26.006 )	22.22 ( 32.530 )
Sexual Function: Cycle 14 (n=25,14)	20.00 ( 27.217 )	26.19 ( 26.726 )
Sexual Function: Cycle 15 (n=21,12)	17.46 ( 27.119 )	19.44 ( 26.432 )
Sexual Function: Cycle 16 (n=19,13)	22.81 ( 33.431 )	25.64 ( 27.735 )
Sexual Function: Cycle 17 (n=15,12)	20.00 ( 27.603 )	22.22 ( 25.950 )
Sexual Function: Cycle 18 (n=12,11)	22.22 ( 21.711 )	18.18 ( 27.340 )
Sexual Function: Cycle 19 (n=7,10)	19.05 ( 26.227 )	20.00 ( 28.109 )
Sexual Function: Cycle 20 (n=8,10)	25.00 ( 29.547 )	13.33 ( 23.307 )
Sexual Function: Cycle 21 (n=7,9)	23.81 ( 25.198 )	14.81 ( 24.216 )
Sexual Function: Cycle 22 (n=8,9)	33.33 ( 30.861 )	14.81 ( 24.216 )
Sexual Function: Cycle 23 (n=7,8)	23.81 ( 31.706 )	20.83 ( 24.801 )
Sexual Function: Cycle 24 (n=5,8)	26.67 ( 27.889 )	16.67 ( 25.198 )
Sexual Function: Cycle 25 (n=5,6)	26.67 ( 36.515 )	16.67 ( 27.889 )
Sexual Function: Cycle 26 (n=4,6)	25.00 ( 31.914 )	16.67 ( 27.889 )
Sexual Function: Cycle 27 (n=1,6)	33.33 ( 99999 )	16.67 ( 27.889 )
Sexual Function: Cycle 28 (n=3,6)	33.33 ( 33.333 )	16.67 ( 27.889 )
Sexual Function: Cycle 29 (n=1,6)	33.33 ( 99999 )	16.67 ( 27.889 )
Sexual Function: Cycle 30 (n=1,6)	33.33 ( 99999 )	16.67 ( 27.889 )
Sexual Function: Cycle 31 (n=1,6)	33.33 ( 99999 )	16.67 ( 27.889 )
Sexual Function: Cycle 32 (n=3,5)	22.22 ( 38.490 )	20.00 ( 29.814 )
Sexual Function: Cycle 33 (n=1,5)	33.33 ( 99999 )	20.00 ( 29.814 )
Sexual Function: Cycle 34 (n=1,5)	33.33 ( 99999 )	33.33 ( 33.333 )
Sexual Function: Cycle 35 (n=1,5)	33.33 ( 99999 )	20.00 ( 29.814 )
Sexual Function: Cycle 36 (n=1,4)	0.00 ( 99999 )	25.00 ( 31.914 )
Sexual Function: Cycle 37 (n=1,3)	0.00 ( 99999 )	33.33 ( 33.333 )
Sexual Function: Cycle 38 (n=0,3)	99999 ( 99999 )	33.33 ( 33.333 )
Sexual Function: Cycle 39 (n=1,2)	33.33 ( 99999 )	16.67 ( 23.570 )
Sexual Function: Cycle 40 (n=1,2)	66.67 ( 99999 )	0.00 ( 0.000 )
Sexual Function: Cycle 41 (n=0,2)	99999 ( 99999 )	16.67 ( 23.570 )
Sexual Function: Cycle 42 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Sexual Function: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Sexual Function: EOT (n=22,19)	25.76 ( 27.084 )	49.12 ( 37.463 )
Information/Communication: Cycle 1 (n=61,44)	8.74 ( 21.860 )	6.82 ( 15.384 )
Information/Communication: Cycle 2 (n=57,41)	5.85 ( 12.791 )	5.69 ( 14.724 )
Information/Communication: Cycle 3 (n=55,40)	5.45 ( 14.001 )	5.00 ( 14.222 )
Information/Communication: Cycle 4 (n=50,38)	4.67 ( 11.684 )	5.26 ( 12.318 )
Information/Communication: Cycle 5 (n=47,33)	3.55 ( 10.389 )	7.07 ( 18.177 )
Information/Communication: Cycle 6 (n=43,31)	4.65 ( 11.687 )	5.38 ( 15.146 )
Information/Communication: Cycle 7 (n=39,29)	6.84 ( 13.636 )	9.20 ( 23.395 )
Information/Communication: Cycle 8 (n=37,25)	8.11 ( 16.491 )	5.33 ( 15.753 )
Information/Communication: Cycle 9 (n=35,26)	5.71 ( 12.746 )	3.85 ( 10.860 )
Information/Communication: Cycle 10 (n=35,23)	8.57 ( 16.848 )	7.25 ( 17.281 )
Information/Communication: Cycle 11 (n=35,24)	7.62 ( 18.232 )	5.56 ( 16.051 )
Information/Communication: Cycle 12 (n=35,22)	10.48 ( 22.537 )	1.52 ( 7.107 )
Information/Communication: Cycle 13 (n=34,21)	3.92 ( 10.901 )	4.76 ( 11.952 )
Information/Communication: Cycle 14 (n=31,19)	6.45 ( 13.387 )	3.51 ( 10.510 )
Information/Communication: Cycle 15 (n=30,17)	4.44 ( 11.525 )	7.84 ( 18.743 )
Information/Communication: Cycle 16 (n=27,16)	2.47 ( 8.896 )	8.33 ( 14.907 )
Information/Communication: Cycle 17 (n=22,15)	4.55 ( 11.708 )	2.22 ( 8.607 )
Information/Communication: Cycle 18 (n=17,14)	7.84 ( 14.575 )	7.14 ( 19.298 )
Information/Communication: Cycle 19 (n=12, 14)	0.00 ( 0.000 )	2.38 ( 8.909 )
Information/Communication: Cycle 20 (n=11,13)	3.03 ( 10.050 )	2.56 ( 9.245 )
Information/Communication: Cycle 21 (n=11,12)	6.06 ( 13.484 )	2.78 ( 9.623 )
Information/Communication: Cycle 22 (n=11,11)	6.06 ( 13.484 )	3.03 ( 10.050 )
Information/Communication: Cycle 23 (n=11,10)	9.09 ( 21.556 )	3.33 ( 10.541 )
Information/Communication: Cycle 24 (n=10,10)	10.00 ( 22.498 )	3.33 ( 10.541 )
Information/Communication: Cycle 25 (n=10,8)	6.67 ( 14.055 )	4.17 ( 11.785 )
Information/Communication: Cycle 26 (n=6,7)	11.11 ( 17.213 )	4.76 ( 12.599 )
Information/Communication: Cycle 27 (n=6,8)	0.00 ( 0.000 )	4.17 ( 11.785 )
Information/Communication: Cycle 28 (n=7,8)	9.52 ( 16.265 )	4.17 ( 11.785 )
Information/Communication: Cycle 29 (n=6,7)	5.56 ( 13.608 )	4.76 ( 12.599 )
Information/Communication: Cycle 30 (n=5,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Information/Communication: Cycle 31 (n=3,7)	0.00 ( 0.000 )	4.76 ( 12.599 )
Information/Communication: Cycle 32 (n=3,6)	0.00 ( 0.000 )	5.56 ( 13.608 )
Information/Communication: Cycle 33 (n=3,6)	11.11 ( 19.245 )	0.00 ( 0.000 )
Information/Communication: Cycle 34 (n=3,6)	11.11 ( 19.245 )	5.56 ( 13.608 )
Information/Communication: Cycle 35 (n=2,6)	0.00 ( 0.000 )	5.56 ( 13.608 )
Information/Communication: Cycle 36 (n=1,5)	0.00 ( 99999 )	0.00 ( 0.000 )
Information/Communication: Cycle 37 (n=1,4)	0.00 ( 99999 )	0.00 ( 0.000 )
Information/Communication: Cycle 38 (n=0,4)	99999 ( 99999 )	8.33 ( 16.667 )
Information/Communication: Cycle 39 (n=1,3)	0.00 ( 99999 )	11.11 ( 19.245 )
Information/Communication: Cycle 40 (n=1,3)	0.00 ( 99999 )	11.11 ( 19.245 )
Information/Communication: Cycle 41 (n=0,3)	99999 ( 99999 )	11.11 ( 19.245 )
Information/Communication: Cycle 42 (n=0,2)	99999 ( 99999 )	0.00 ( 0.000 )
Information/Communication: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Information/Communication: EOT (n=33,29)	10.10 ( 19.516 )	5.75 ( 20.057 )
Body Image: Cycle 1 (n=60,44)	21.67 ( 32.950 )	24.24 ( 24.234 )
Body Image: Cycle 2 (n=57,41)	12.87 ( 19.674 )	15.45 ( 25.925 )
Body Image: Cycle 3 (n=52,40)	10.90 ( 21.614 )	19.17 ( 31.020 )
Body Image: Cycle 4 (n=49,38)	10.88 ( 17.197 )	16.67 ( 24.199 )
Body Image: Cycle 5 (n=46,33)	8.70 ( 17.826 )	15.15 ( 25.126 )
Body Image: Cycle 6 (n=42,30)	11.90 ( 21.866 )	21.11 ( 29.664 )
Body Image: Cycle 7 (n=38,28)	14.91 ( 25.347 )	21.43 ( 31.706 )
Body Image: Cycle 8 (n=37,24)	13.51 ( 24.164 )	15.28 ( 24.035 )
Body Image: Cycle 9 (n=35,25)	14.29 ( 28.337 )	14.67 ( 23.727 )
Body Image: Cycle 10 (n=34,23)	13.73 ( 24.779 )	18.84 ( 26.258 )
Body Image: Cycle 11 (n=35,24)	12.38 ( 19.944 )	15.28 ( 24.035 )
Body Image: Cycle 12 (n=35,22)	10.48 ( 21.038 )	9.09 ( 23.417 )
Body Image: Cycle 13 (n=34,21)	7.84 ( 20.199 )	7.94 ( 17.965 )
Body Image: Cycle 14 (n=31,19)	12.90 ( 23.847 )	7.02 ( 13.962 )
Body Image: Cycle 15 (n=29,17)	9.20 ( 21.633 )	9.80 ( 19.596 )
Body Image: Cycle 16 (n=27,16)	16.05 ( 28.300 )	10.42 ( 23.472 )
Body Image: Cycle 17 (n=22,15)	12.12 ( 26.318 )	8.89 ( 15.258 )
Body Image: Cycle 18 (n=17,14)	15.69 ( 31.441 )	7.14 ( 14.194 )
Body Image: Cycle 19 (n=12,14)	11.11 ( 25.950 )	2.38 ( 8.909 )
Body Image: Cycle 20 (n=11,12)	9.09 ( 30.151 )	8.33 ( 15.076 )
Body Image: Cycle 21 (n=11,12)	9.09 ( 30.151 )	2.78 ( 9.623 )
Body Image: Cycle 22 (n=11,11)	15.15 ( 31.140 )	6.06 ( 13.484 )
Body Image: Cycle 23 (n=11,10)	9.09 ( 21.556 )	6.67 ( 14.055 )
Body Image: Cycle 24 (n=10,10)	16.67 ( 36.004 )	3.33 ( 10.541 )
Body Image: Cycle 25 (n=10,8)	16.67 ( 36.004 )	8.33 ( 15.430 )
Body Image: Cycle 26 (n=7,7)	23.81 ( 41.786 )	4.76 ( 12.599 )
Body Image: Cycle 27 (n=6,8)	22.22 ( 40.369 )	4.17 ( 11.785 )
Body Image: Cycle 28 (n=6,8)	22.22 ( 40.369 )	12.50 ( 17.252 )
Body Image: Cycle 29 (n=6,7)	11.11 ( 27.217 )	0.00 ( 0.000 )
Body Image: Cycle 30 (n=5,7)	0.00 ( 0.000 )	0.00 ( 0.000 )
Body Image: Cycle 31 (n=3,7)	0.00 ( 0.000 )	0.00 ( 0.000 )
Body Image: Cycle 32 (n=3,6)	0.00 ( 0.000 )	0.00 ( 0.000 )
Body Image: Cycle 33 (n=3,6)	0.00 ( 0.000 )	5.56 ( 13.608 )
Body Image: Cycle 34 (n=3,6)	22.22 ( 38.490 )	5.56 ( 13.608 )
Body Image: Cycle 35 (n=2,6)	16.67 ( 23.570 )	11.11 ( 17.213 )
Body Image: Cycle 36 (n=1,5)	0.00 ( 99999 )	0.00 ( 0.000 )
Body Image: Cycle 37 (n=1,4)	0.00 ( 99999 )	8.33 ( 16.667 )
Body Image: Cycle 38 (n=0,4)	99999 ( 99999 )	8.33 ( 16.667 )
Body Image: Cycle 39 (n=1,3)	0.00 ( 99999 )	22.22 ( 38.490 )
Body Image: Cycle 40 (n=1,3)	0.00 ( 99999 )	0.00 ( 0.000 )
Body Image: Cycle 41 (n=0,3)	99999 ( 99999 )	11.11 ( 19.245 )
Body Image: Cycle 42 (n=0,2)	99999 ( 99999 )	0.00 ( 0.000 )
Body Image: Cycle 43 (n=0,1)	99999 ( 99999 )	0.00 ( 99999 )
Body Image: EOT (n=33,29)	23.23 ( 32.792 )	18.39 ( 31.605 )

No statistical analyses for this end point

Secondary: Plasma Concentration of Soluble Protein Biomarker (sKIT)

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End point title

Plasma Concentration of Soluble Protein Biomarker (sKIT)

End point description

sKIT analysis set included all enrolled subjects who received at least 1 dose of study drug and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment. Here, "99999" for mean and standard deviation signifies data not available (NA) as none of the subjects were evaluable in the given group at specified time point. Here, 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.

End point type

Secondary

End point 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 1226 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	58	45
Units: picogram per milliliter (pcg/mL)
arithmetic mean (standard deviation)
Cycle1/Day1 (n =58, 45)	58218.8 ( 18406.35 )	62267.7 ( 17298.53 )
Cycle1/Day15 (n =58, 44)	51614.2 ( 18638.21 )	48946.4 ( 15189.15 )
Cycle2/Day1 (n= 56, 44)	37705.1 ( 14128.27 )	40334.8 ( 14304.02 )
Cycle3/Day1 (n =52, 41)	26939.9 ( 10839.77 )	30224.0 ( 13709.28 )
Cycle5/Day1 (n= 46, 35)	20596.1 ( 7331.69 )	23892.6 ( 11355.85 )
Cycle7/Day1 (n =38, 29)	18222.9 ( 8010.89 )	19786.4 ( 10564.09 )
Cycle9/Day1 (n =32, 24)	17677.0 ( 6179.43 )	19761.3 ( 12429.49 )
Cycle11/Day1 (n =33, 23)	16689.8 ( 7452.02 )	21091.1 ( 13222.55 )
Cycle13/Day1 (n =30, 20)	16657.7 ( 8876.97 )	18103.0 ( 7763.15 )
Cycle15/Day1 (n =28, 14)	15675.0 ( 6591.98 )	16222.5 ( 4939.29 )
Cycle17/Day1 (n =21, 15)	15705.5 ( 5665.32 )	15769.0 ( 7628.43 )
Cycle19/Day1 (n =12, 13)	14600.0 ( 4537.41 )	15811.2 ( 7297.71 )
Cycle21/Day1 (n =11, 10)	14809.5 ( 4395.74 )	15577.0 ( 5782.28 )
Cycle23/Day1 (n =11, 8)	13332.3 ( 3670.43 )	12238.8 ( 4252.01 )
Cycle25/Day1 (n =10, 7)	13674.0 ( 5440.63 )	13112.1 ( 5057.35 )
Cycle27/Day1 (n =5, 8)	12616.0 ( 3513.31 )	16553.1 ( 8092.47 )
Cycle29/Day1 (n =4, 7)	13638.8 ( 3555.38 )	16261.4 ( 10057.56 )
Cycle31/Day1 (n =2, 6)	9567.5 ( 1644.02 )	10950.8 ( 4149.34 )
Cycle33/Day1 (n =2, 6)	9440.0 ( 1541.49 )	10590.0 ( 4008.65 )
Cycle35/Day1 (n =1, 6)	11255.0 ( 99999 )	10241.7 ( 2748.91 )
Cycle37/Day1 (n =0, 4)	99999 ( 99999 )	9038.8 ( 3243.45 )
Cycle39/Day1 (n =0, 2)	99999 ( 99999 )	8672.5 ( 477.30 )
Cycle41/Day1 (n =0, 3)	99999 ( 99999 )	7023.3 ( 1849.00 )
Cycle43/Day1 (n =0, 1)	99999 ( 99999 )	9360.0 ( 99999 )
EOT (n= 30, 28)	21680.3 ( 10358.35 )	22605.5 ( 10953.00 )

No statistical analyses for this end point

Secondary: Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and its Metabolite SU012662

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End point title

Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and its Metabolite SU012662

End point description

Ctrough is the plasma concentration of sunitinib prior to study drug administration (lowest level at which a drug is present in the body). 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. Here, 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.

End point type

Secondary

End point timeframe

Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: nanogram per milliliter (ng/mL)
arithmetic mean (standard deviation)
Sunitinib: Cycle1/Day15 (n =60, 44)	52.78 ( 27.361 )	41.93 ( 21.707 )
Sunitinib: Cycle2/Day1 (n =57, 44)	42.68 ( 20.320 )	38.38 ( 22.765 )
Sunitinib: Cycle3/Day1 (n =54, 41)	41.79 ( 21.517 )	38.49 ( 18.750 )
Sunitinib: Cycle5/Day1 (n =48, 35)	35.57 ( 15.221 )	33.60 ( 15.010 )
SU012662: Cycle1/Day15 (n =60, 44)	18.03 ( 11.169 )	14.26 ( 9.264 )
SU012662: Cycle2/Day1 (n =57, 44)	15.94 ( 9.059 )	12.53 ( 8.000 )
SU012662: Cycle3/Day1 (n =54, 41)	15.85 ( 9.444 )	13.64 ( 6.983 )
SU012662: Cycle5/Day1 (n =48, 35)	12.78 ( 6.375 )	12.61 ( 6.735 )

No statistical analyses for this end point

Secondary: Dose-Corrected Trough Plasma Concentration of Sunitinib and its Metabolite SU012662

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End point title

Dose-Corrected Trough Plasma Concentration of Sunitinib and its Metabolite SU012662

End point description

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 subject had received over the last 10 consecutive days prior sampling. SU012662 is the metabolite of sunitininb. 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. Here, 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.

End point type

Secondary

End point timeframe

Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: ng/mL
arithmetic mean (standard deviation)
Sunitinib: Cycle1/Day15 (n =59, 40)	52.66 ( 27.136 )	43.38 ( 21.520 )
Sunitinib: Cycle2/Day1 (n =55, 36)	42.89 ( 20.607 )	39.52 ( 19.833 )
Sunitinib: Cycle3/Day1 (n =49, 39)	44.99 ( 23.031 )	38.56 ( 18.375 )
Sunitinib: Cycle5/Day1 (n =43, 35)	42.49 ( 16.769 )	33.27 ( 16.733 )
SU012662: Cycle1/Day15 (n =59, 40)	18.14 ( 11.059 )	14.79 ( 9.436 )
SU012662: Cycle2/Day1 (n =55, 36)	16.01 ( 9.132 )	13.09 ( 7.684 )
SU012662: Cycle3/Day1 (n =49, 39)	17.37 ( 10.233 )	14.22 ( 7.085 )
SU012662: Cycle5/Day1 (n =43, 35)	15.35 ( 6.882 )	12.53 ( 6.914 )

No statistical analyses for this end point

Secondary: Area Under the Curve (AUC24) of Sunitinib and its Metabolite SU012662

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End point title

Area Under the Curve (AUC24) of Sunitinib and its Metabolite SU012662

End point description

Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitininb.

End point type

Secondary

End point 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)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	0 ^[2]	0 ^[3]
Units: (nanogram*hour) per milliliter
arithmetic mean (standard deviation)	( )	( )

Notes
[2] - Data for this secondary endpoint is not available and shall be posted in April 2017.
[3] - Data for this secondary endpoint is not available and shall be posted in April 2017.

No statistical analyses for this end point

Secondary: Oral Clearance (CL/F) of Sunitinib and its Metabolite SU012662

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End point title

Oral Clearance (CL/F) of Sunitinib and its Metabolite SU012662

End point description

Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

End point type

Secondary

End point timeframe

Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	0 ^[4]	0 ^[5]
Units: milliliter per minute
arithmetic mean (standard deviation)	( )	( )

Notes
[4] - Data for this secondary endpoint is not available and shall be posted in April 2017.
[5] - Data for this secondary endpoint is not available and shall be posted in April 2017.

No statistical analyses for this end point

Secondary: Half Maximal Effective Concentration (EC50) of Sunitinib

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End point title

Half Maximal Effective Concentration (EC50) of Sunitinib

End point description

Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.

End point type

Secondary

End point timeframe

Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	0 ^[6]	0 ^[7]
Units: milligram per milliliter
arithmetic mean (standard deviation)	( )	( )

Notes
[6] - Data for this secondary endpoint is not available and shall be posted in April 2017.
[7] - Data for this secondary endpoint is not available and shall be posted in April 2017.

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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End point title

Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

End point description

An AE was any untoward medical occurrence in a subject 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. Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects
AEs	59	45
SAEs	17	12

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

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End point title

Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

End point description

Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject 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. Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects
AEs	57	44
SAEs	9	3

No statistical analyses for this end point

Secondary: Number of Subjects With Adverse Events (AEs) According to Severity

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End point title

Number of Subjects With Adverse Events (AEs) According to Severity

End point description

An AE was any untoward medical occurrence in a subject 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. Safety analysis set included all subjects who received at least 1 dose of study medication. Here, "number of subjects analyzed" signifies subjects who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	59	45
Units: subjects
Grade 1	4	5
Grade 2	9	9
Grade 3	38	23
Grade 4	6	6
Grade 5	2	2

No statistical analyses for this end point

Secondary: Number of Subjects With Clinically Significant Laboratory Abnormalities

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End point title

Number of Subjects With Clinically Significant Laboratory Abnormalities

End point description

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. Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects	30	22

No statistical analyses for this end point

Secondary: Number of Subjects With Change From Baseline in Vital Signs Abnormalities

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End point title

Number of Subjects With Change From Baseline in Vital Signs Abnormalities

End point description

Criteria for change in vital signs were defined as: >=20 mmHg or >=40 mmHg or >=60 mmHg increase from baseline in systolic blood pressure (SBP); >=10 mmHg or >=20 mmHg or >=30 mmHg increase from baseline in diastolic blood pressure (DBP); increase of >=1.1 degree Celsius in baseline body temperature (temp.) if the baseline temperature is >36.8 degree Celsius. Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects
SBP: increase from baseline >=20	31	23
SBP: increase from baseline >=40	6	9
SBP: increase from baseline >=60	3	3
DBP: increase from baseline >=10	41	35
DBP: increase from baseline >=20	15	19
DBP: increase from baseline >=30	6	6
Temp.: increase from baseline >=1.1 degree Celsius	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Increase From Baseline in Corrected QT Interval (QTc)

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End point title

Number of Subjects With Increase From Baseline in Corrected QT Interval (QTc)

End point description

QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF). Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects
QTcB	0	0
QTcF	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With Change From Baseline in Physical Examinations Findings

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End point title

Number of Subjects With Change From Baseline in Physical Examinations Findings

End point description

Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects	23	19

No statistical analyses for this end point

Secondary: Number of Subjects With Change From Baseline in Body Weight

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End point title

Number of Subjects With Change From Baseline in Body Weight

End point description

Subjects with increase of >=5 percent and decrease of >=5 percent from baseline in body weight were reported in this outcome measure. Safety analysis set included all subjects who received at least 1 dose of study medication.

End point type

Secondary

End point timeframe

Baseline up to 1939 days

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects
Increase of >=5 percent	27	9
Decrease of >=5 percent	18	15

No statistical analyses for this end point

Secondary: Number of Subjects With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)

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End point title

Number of Subjects With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)

End point description

ECOG-PS is used to assess how disease affects daily living abilities of subject and measured on 6-point scale ranging from 0-5 (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% 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% of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. Higher score=greater functional impairment. Only those ECOG-PS categories, in which at least one subject had data at any indicated time point were reported in this outcome measure. Subject with not reported (NR) category did not provided any ECOG performance status. Safety analysis set and 'n' signifies those subjects who were evaluable at specified time point for each arm.

End point type

Secondary

End point timeframe

End point values	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Number of subjects analysed	61	45
Units: subjects
Cycle 1/Day 1: ECOG-PS =0 (n=61,45)	37	25
Cycle 1/Day 1: ECOG-PS =1 (n=61,45)	15	14
Cycle 1/Day 1: ECOG-PS =NR (n=61,45)	9	6
Cycle 2/Day 1: ECOG-PS =0 (n=59,44)	37	30
Cycle 2/Day 1: ECOG-PS =1 (n=59,44)	19	13
Cycle 2/Day 1: ECOG-PS =NR (n=59,44)	3	1
Cycle 3/Day 1: ECOG-PS =0 (n=56,41)	37	29
Cycle 3/Day 1: ECOG-PS =1 (n=56,41)	17	10
Cycle 3/Day 1: ECOG-PS =2 (n=56,41)	0	1
Cycle 3/Day 1: ECOG-PS =3 (n=56,41)	0	1
Cycle 3/Day 1: ECOG-PS =NR (n=56,41)	2	0
Cycle 4/Day 1: ECOG-PS =0 (n=51,39)	34	25
Cycle 4/Day 1: ECOG-PS =1 (n=51,39)	15	13
Cycle 4/Day 1: ECOG-PS =NR (n=51,39)	2	1
Cycle 5/Day 1: ECOG-PS =0 (n=48,35)	34	23
Cycle 5/Day 1: ECOG-PS =1 (n=48,35)	13	11
Cycle 5/Day 1: ECOG-PS =2 (n=48,35)	1	1
Cycle 6/Day 1: ECOG-PS =0 (n=43,31)	30	21
Cycle 6/Day 1: ECOG-PS =1 (n=43,31)	13	9
Cycle 6/Day 1: ECOG-PS =2 (n=43,31)	0	1
Cycle 7/Day 1: ECOG-PS =0 (n=40,29)	27	21
Cycle 7/Day 1: ECOG-PS =1 (n=40,29)	13	7
Cycle 7/Day 1: ECOG-PS =2 (n=40,29)	0	1
Cycle 8/Day 1: ECOG-PS =0 (n=37,26)	24	20
Cycle 8/Day 1: ECOG-PS =1 (n=37,26)	13	6
Cycle 9/Day 1: ECOG-PS =0 (n=35,26)	24	20
Cycle 9/Day 1: ECOG-PS =1 (n=35,26)	11	6
Cycle 10/Day 1: ECOG-PS =0 (n=35,25)	22	18
Cycle 10/Day 1: ECOG-PS =1 (n=35,25)	13	6
Cycle 10/Day 1: ECOG-PS =NR (n=35,25)	0	1
Cycle 11/Day 1: ECOG-PS =0 (n=35,24)	22	18
Cycle 11/Day 1: ECOG-PS =1 (n=35,24)	13	6
Cycle 12/Day 1: ECOG-PS =0 (n=35,22)	22	16
Cycle 12/Day 1: ECOG-PS =1 (n=35,22)	13	6
Cycle 13/Day 1: ECOG-PS =0 (n=34,21)	21	15
Cycle 13/Day 1: ECOG-PS =1 (n=34,21)	13	6
Cycle 14/Day 1: ECOG-PS =0 (n=31,20)	19	12
Cycle 14/Day 1: ECOG-PS =1 (n=31,20)	11	6
Cycle 14/Day 1: ECOG-PS =NR (n=31,20)	1	2
Cycle 15/Day 1: ECOG-PS =0 (n=30,17)	20	13
Cycle 15/Day 1: ECOG-PS =1 (n=30,17)	10	4
Cycle 16/Day 1: ECOG-PS =0 (n=27,16)	16	13
Cycle 16/Day 1: ECOG-PS =1 (n=27,16)	10	3
Cycle 16/Day 1: ECOG-PS =NR (n=27,16)	1	0
Cycle 17/Day 1: ECOG-PS =0 (n=22,15)	15	13
Cycle 17/Day 1: ECOG-PS =1 (n=22,15)	6	2
Cycle 17/Day 1: ECOG-PS =NR (n=22,15)	1	0
Cycle 18/Day 1: ECOG-PS =0 (n=17,14)	10	12
Cycle 18/Day 1: ECOG-PS =1 (n=17,14)	5	1
Cycle 18/Day 1: ECOG-PS =NR (n=17,14)	2	1
Cycle 19/Day 1: ECOG-PS =0 (n=12,14)	8	12
Cycle 19/Day 1: ECOG-PS =1 (n=12,14)	3	1
Cycle 19/Day 1: ECOG-PS =2 (n=12,14)	1	0
Cycle 19/Day 1: ECOG-PS =NR (n=12,14)	0	1
Cycle 20/Day 1: ECOG-PS =0 (n=12,13)	8	11
Cycle 20/Day 1: ECOG-PS =1 (n=12,13)	2	1
Cycle 20/Day 1: ECOG-PS =2 (n=12,13)	1	0
Cycle 20/Day 1: ECOG-PS =NR (n=12,13)	1	1
Cycle 21/Day 1: ECOG-PS =0 (n=11,12)	7	9
Cycle 21/Day 1: ECOG-PS =1 (n=11,12)	4	2
Cycle 21/Day 1: ECOG-PS =NR (n=11,12)	0	1
Cycle 22/Day 1: ECOG-PS =0 (n=11,11)	8	8
Cycle 22/Day 1: ECOG-PS =1 (n=11,11)	3	1
Cycle 22/Day 1: ECOG-PS =3 (n=11,11)	0	1
Cycle 22/Day 1: ECOG-PS =NR (n=11,11)	0	1
Cycle 23/Day 1: ECOG-PS =0 (n=11,10)	8	7
Cycle 23/Day 1: ECOG-PS =1 (n=11,10)	2	2
Cycle 23/Day 1: ECOG-PS =NR (n=11,10)	1	1
Cycle 24/Day 1: ECOG-PS =0 (n=10,10)	9	7
Cycle 24/Day 1: ECOG-PS =1 (n=10,10)	0	2
Cycle 24/Day 1: ECOG-PS =2 (n=10,10)	1	0
Cycle 24/Day 1: ECOG-PS =NR (n=10,10)	0	1
Cycle 25/Day 1: ECOG-PS =0 (n=10,8)	8	6
Cycle 25/Day 1: ECOG-PS =1 (n=10,8)	1	1
Cycle 25/Day 1: ECOG-PS =2 (n=10,8)	1	0
Cycle 25/Day 1: ECOG-PS =NR (n=10,8)	0	1
Cycle 26/Day 1: ECOG-PS =0 (n=7,8)	5	7
Cycle 26/Day 1: ECOG-PS =1 (n=7,8)	1	1
Cycle 26/Day 1: ECOG-PS =2 (n=7,8)	1	0
Cycle 27/Day 1: ECOG-PS =0 (n=7,8)	4	7
Cycle 27/Day 1: ECOG-PS =1 (n=7,8)	1	1
Cycle 27/Day 1: ECOG-PS =2 (n=7,8)	1	0
Cycle 27/Day 1: ECOG-PS =NR (n=7,8)	1	0
Cycle 28/Day 1: ECOG-PS =0 (n=7,8)	5	6
Cycle 28/Day 1: ECOG-PS =1 (n=7,8)	1	1
Cycle 28/Day 1: ECOG-PS =2 (n=7,8)	1	0
Cycle 28/Day 1: ECOG-PS =NR (n=7,8)	0	1
Cycle 29/Day 1: ECOG-PS =0 (n=6,7)	5	6
Cycle 29/Day 1: ECOG-PS =1 (n=6,7)	1	0
Cycle 29/Day 1: ECOG-PS =NR (n=6,7)	0	1
Cycle 30/Day 1: ECOG-PS =0 (n=5,7)	5	6
Cycle 30/Day 1: ECOG-PS =NR (n=5,7)	0	1
Cycle 31/Day 1: ECOG-PS =0 (n=3,7)	2	5
Cycle 31/Day 1: ECOG-PS =1 (n=3,7)	1	1
Cycle 31/Day 1: ECOG-PS =NR (n=3,7)	0	1
Cycle 32/Day 1: ECOG-PS =0 (n=3,6)	3	5
Cycle 32/Day 1: ECOG-PS =NR (n=3,6)	0	1
Cycle 33/Day 1: ECOG-PS =0 (n=3,6)	2	4
Cycle 33/Day 1: ECOG-PS =1 (n=3,6)	1	1
Cycle 33/Day 1: ECOG-PS =NR (n=3,6)	0	1
Cycle 34/Day 1: ECOG-PS =0 (n=3,6)	3	4
Cycle 34/Day 1: ECOG-PS =1 (n=3,6)	0	1
Cycle 34/Day 1: ECOG-PS =NR (n=3,6)	0	1
Cycle 35/Day 1: ECOG-PS =0 (n=2,6)	2	4
Cycle 35/Day 1: ECOG-PS =1 (n=2,6)	0	1
Cycle 35/Day 1: ECOG-PS =NR (n=2,6)	0	1
Cycle 36/Day 1: ECOG-PS =0 (n=1,5)	1	3
Cycle 36/Day 1: ECOG-PS =1 (n=1,5)	0	1
Cycle 36/Day 1: ECOG-PS =NR (n=1,5)	0	1
Cycle 37/Day 1: ECOG-PS =0 (n=1,4)	1	2
Cycle 37/Day 1: ECOG-PS =1 (n=1,4)	0	1
Cycle 37/Day 1: ECOG-PS =NR (n=1,4)	0	1
Cycle 38/Day 1: ECOG-PS =0 (n=1,4)	1	3
Cycle 38/Day 1: ECOG-PS =1 (n=1,4)	0	1
Cycle 39/Day 1: ECOG-PS =0 (n=1,3)	1	1
Cycle 39/Day 1: ECOG-PS =1 (n=1,3)	0	2
Cycle 40/Day 1: ECOG-PS =0 (n=1,3)	0	1
Cycle 40/Day 1: ECOG-PS =1 (n=1,3)	1	2
Cycle 41/Day 1: ECOG-PS =0 (n=0,3)	0	1
Cycle 41/Day 1: ECOG-PS =1 (n=0,3)	0	1
Cycle 41/Day 1: ECOG-PS =NR (n=0,3)	0	1
Cycle 42/Day 1: ECOG-PS =1 (n=0,2)	0	2
Cycle 43/Day 1: ECOG-PS =1 (n=0,1)	0	1
EOT: ECOG-PS =0 (n=43,38)	20	14
EOT: ECOG-PS =1 (n=43,38)	13	12
EOT: ECOG-PS =2 (n=43,38)	0	4
EOT: ECOG-PS =3 (n=43,38)	1	1
EOT: ECOG-PS =NR (n=43,38)	9	7

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline up to 1939 days

Adverse event reporting additional description

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Sunitinib: Treatment Naive Cohort

Reporting group description

Reporting group title

Sunitinib: Later-Line Cohort

Reporting group description

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).

Serious adverse events	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Total subjects affected by serious adverse events
subjects affected / exposed	17 / 61 (27.87%)	12 / 45 (26.67%)
number of deaths (all causes)	3	2
number of deaths resulting from adverse events
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebral haemorrhage
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Disease progression
subjects affected / exposed	2 / 61 (3.28%)	2 / 45 (4.44%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Immune system disorders
Hypersensitivity
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal stenosis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-alcoholic steatohepatitis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Urosepsis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Peritonitis bacterial
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Sunitinib: Treatment Naive Cohort	Sunitinib: Later-Line Cohort
Total subjects affected by non serious adverse events
subjects affected / exposed	59 / 61 (96.72%)	45 / 45 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	3	1
Flushing
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	3	0
Haemorrhage
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	2	0
Hot flush
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hypertension
subjects affected / exposed	16 / 61 (26.23%)	13 / 45 (28.89%)
occurrences all number	39	27
Surgical and medical procedures
Hospitalisation
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Tooth extraction
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	11 / 61 (18.03%)	7 / 45 (15.56%)
occurrences all number	24	27
Chest pain
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Discomfort
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Face oedema
subjects affected / exposed	3 / 61 (4.92%)	1 / 45 (2.22%)
occurrences all number	4	1
Facial pain
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Fatigue
subjects affected / exposed	20 / 61 (32.79%)	13 / 45 (28.89%)
occurrences all number	42	19
Feeling cold
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Gait disturbance
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
General physical health deterioration
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	2
Hyperpyrexia
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Influenza like illness
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Malaise
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	4	1
Mucosal inflammation
subjects affected / exposed	6 / 61 (9.84%)	5 / 45 (11.11%)
occurrences all number	6	8
Mucous membrane disorder
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Oedema
subjects affected / exposed	5 / 61 (8.20%)	2 / 45 (4.44%)
occurrences all number	6	2
Oedema peripheral
subjects affected / exposed	5 / 61 (8.20%)	3 / 45 (6.67%)
occurrences all number	7	4
Pain
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	1	4
Pyrexia
subjects affected / exposed	6 / 61 (9.84%)	8 / 45 (17.78%)
occurrences all number	7	11
Immune system disorders
Contrast media allergy
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hypersensitivity
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Reproductive system and breast disorders
Genital erythema
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Menstruation irregular
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Penile erythema
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	4
Perineal pain
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Vaginal haemorrhage
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Vaginal inflammation
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	6	0
Vulvovaginal inflammation
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	6	0
Respiratory, thoracic and mediastinal disorders
Choking
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Cough
subjects affected / exposed	2 / 61 (3.28%)	6 / 45 (13.33%)
occurrences all number	2	8
Dysphonia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Dyspnoea
subjects affected / exposed	2 / 61 (3.28%)	4 / 45 (8.89%)
occurrences all number	5	6
Dyspnoea exertional
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Epistaxis
subjects affected / exposed	7 / 61 (11.48%)	5 / 45 (11.11%)
occurrences all number	15	5
Haemoptysis
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	3	0
Nasal disorder
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Nasal septum ulceration
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Oropharyngeal pain
subjects affected / exposed	4 / 61 (6.56%)	5 / 45 (11.11%)
occurrences all number	4	8
Productive cough
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Rhinitis allergic
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Upper respiratory tract congestion
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Pneumonitis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Pulmonary embolism
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	2	0
Psychiatric disorders
Anxiety
subjects affected / exposed	2 / 61 (3.28%)	2 / 45 (4.44%)
occurrences all number	2	3
Depressed mood
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Hallucination
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Insomnia
subjects affected / exposed	0 / 61 (0.00%)	3 / 45 (6.67%)
occurrences all number	0	4
Investigations
Alanine aminotransferase increased
subjects affected / exposed	3 / 61 (4.92%)	8 / 45 (17.78%)
occurrences all number	6	10
Aspartate aminotransferase increased
subjects affected / exposed	5 / 61 (8.20%)	7 / 45 (15.56%)
occurrences all number	9	13
Blood alkaline phosphatase increased
subjects affected / exposed	2 / 61 (3.28%)	3 / 45 (6.67%)
occurrences all number	5	3
Blood bilirubin increased
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	2	3
Blood chloride decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood chromogranin A increased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood creatinine increased
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	1	4
Blood folate decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood glucose increased
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	3	0
Blood iron decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood lactate dehydrogenase increased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood phosphorus decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood potassium decreased
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	8	0
Blood pressure increased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Blood thyroid stimulating hormone abnormal
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood thyroid stimulating hormone increased
subjects affected / exposed	5 / 61 (8.20%)	2 / 45 (4.44%)
occurrences all number	6	2
Blood triglycerides increased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Blood urine present
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	4	0
C-reactive protein increased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Ejection fraction decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Electrocardiogram T wave abnormal
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	3	1
Electrocardiogram abnormal
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Gamma-glutamyltransferase increased
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	4	1
Glomerular filtration rate decreased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Haemoglobin decreased
subjects affected / exposed	4 / 61 (6.56%)	2 / 45 (4.44%)
occurrences all number	23	6
Neutrophil count
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Neutrophil count decreased
subjects affected / exposed	5 / 61 (8.20%)	3 / 45 (6.67%)
occurrences all number	50	18
Occult blood positive
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Platelet count decreased
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	15	0
Protein urine
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	2	0
Protein urine present
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	2	6
Red blood cell count decreased
subjects affected / exposed	2 / 61 (3.28%)	3 / 45 (6.67%)
occurrences all number	3	5
Red blood cells urine positive
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Thyroxine free decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Transaminases increased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Tri-iodothyronine decreased
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	5	0
Tri-iodothyronine free decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	3	0
Urinary sediment present
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	3	0
Urobilinogen urine increased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Vitamin B12 decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Weight decreased
subjects affected / exposed	11 / 61 (18.03%)	7 / 45 (15.56%)
occurrences all number	14	9
Weight increased
subjects affected / exposed	5 / 61 (8.20%)	2 / 45 (4.44%)
occurrences all number	5	6
White blood cell count
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
White blood cell count decreased
subjects affected / exposed	6 / 61 (9.84%)	1 / 45 (2.22%)
occurrences all number	39	2
White blood cells urine positive
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	4	0
Blood potassium increased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Blood albumin decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Electrocardiogram ST segment abnormal
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	3	0
Glucose urine present
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Glutathione s-transferase increased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Procalcitonin increased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Protein total decreased
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Thyroid hormones decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Lymphocyte count decreased
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Total bile acids increased
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hypoalbuminaemia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	2
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Fall
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Limb injury
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	2	0
Overdose
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Skin abrasion
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Skin wound
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Sunburn
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Tooth fracture
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Wound
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Chillblains
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Cardiac disorders
Cardiac failure
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Cardiovascular symptom
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Nodal arrhythmia
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Palpitations
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	2
Tachycardia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	3	0
Ventricular extrasystoles
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Nervous system disorders
Amnesia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Cognitive disorder
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Dizziness
subjects affected / exposed	3 / 61 (4.92%)	7 / 45 (15.56%)
occurrences all number	4	9
Dysaesthesia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Dysgeusia
subjects affected / exposed	14 / 61 (22.95%)	11 / 45 (24.44%)
occurrences all number	21	15
Headache
subjects affected / exposed	12 / 61 (19.67%)	9 / 45 (20.00%)
occurrences all number	17	23
Hyperaesthesia
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Hypogeusia
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	4	1
Memory impairment
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Neuropathy peripheral
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	2
Neurotoxicity
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Paraesthesia
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	3	0
Polyneuropathy
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Facial paralysis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	11 / 61 (18.03%)	9 / 45 (20.00%)
occurrences all number	18	33
Leukopenia
subjects affected / exposed	26 / 61 (42.62%)	21 / 45 (46.67%)
occurrences all number	144	111
Lymphopenia
subjects affected / exposed	4 / 61 (6.56%)	3 / 45 (6.67%)
occurrences all number	10	12
Neutropenia
subjects affected / exposed	37 / 61 (60.66%)	23 / 45 (51.11%)
occurrences all number	246	116
Thrombocytopenia
subjects affected / exposed	18 / 61 (29.51%)	15 / 45 (33.33%)
occurrences all number	72	29
Bone marrow failure
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Eye disorders
Cataract
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Dry eye
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	5
Eye haemorrhage
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Eyelid bleeding
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Eyelid disorder
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Eyelid oedema
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	2	1
Keratitis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Lacrimation increased
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	3	0
Periorbital oedema
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	4
Retinal vascular disorder
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Vision blurred
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	3	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	3
Abdominal distension
subjects affected / exposed	4 / 61 (6.56%)	3 / 45 (6.67%)
occurrences all number	4	3
Abdominal pain
subjects affected / exposed	15 / 61 (24.59%)	8 / 45 (17.78%)
occurrences all number	20	14
Abdominal pain lower
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Abdominal pain upper
subjects affected / exposed	5 / 61 (8.20%)	7 / 45 (15.56%)
occurrences all number	6	13
Abdominal tenderness
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Anal inflammation
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	3	9
Aphthous ulcer
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	4	0
Ascites
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	1	3
Constipation
subjects affected / exposed	3 / 61 (4.92%)	7 / 45 (15.56%)
occurrences all number	4	7
Diarrhoea
subjects affected / exposed	33 / 61 (54.10%)	22 / 45 (48.89%)
occurrences all number	118	87
Dry mouth
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	2	1
Duodenal stenosis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Dyspepsia
subjects affected / exposed	7 / 61 (11.48%)	14 / 45 (31.11%)
occurrences all number	12	21
Dysphagia
subjects affected / exposed	2 / 61 (3.28%)	3 / 45 (6.67%)
occurrences all number	2	4
Epigastric discomfort
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Eructation
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Flatulence
subjects affected / exposed	3 / 61 (4.92%)	1 / 45 (2.22%)
occurrences all number	4	3
Frequent bowel movements
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Gastritis
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	2
Gastrooesophageal reflux disease
subjects affected / exposed	4 / 61 (6.56%)	4 / 45 (8.89%)
occurrences all number	5	4
Gingival bleeding
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	4	0
Gingival pain
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Gingival swelling
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Glossodynia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Haemorrhoids
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Hyperchlorhydria
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Lip dry
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Melaena
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Mouth ulceration
subjects affected / exposed	4 / 61 (6.56%)	5 / 45 (11.11%)
occurrences all number	4	6
Nausea
subjects affected / exposed	14 / 61 (22.95%)	14 / 45 (31.11%)
occurrences all number	24	33
Oral dysaesthesia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Oral mucosal blistering
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Oral pain
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	1	4
Pancreatitis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Periodontal disease
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Proctalgia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Proctitis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Rectal haemorrhage
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Regurgitation
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	3	0
Salivary hypersecretion
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Stomatitis
subjects affected / exposed	15 / 61 (24.59%)	6 / 45 (13.33%)
occurrences all number	42	22
Toothache
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	3
Vomiting
subjects affected / exposed	8 / 61 (13.11%)	10 / 45 (22.22%)
occurrences all number	17	14
Faeces pale
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Gastrointestinal disorder
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hepatobiliary disorders
Ocular icterus
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Cholangitis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Hepatic function abnormal
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	3	0
Hepatomegaly
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	2
Hyperbilirubinaemia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	7	1
Hypertransaminasaemia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Jaundice
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Liver injury
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Cholecystitis chronic
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Alopecia
subjects affected / exposed	7 / 61 (11.48%)	1 / 45 (2.22%)
occurrences all number	8	1
Blister
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Cold sweat
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Dermatitis
subjects affected / exposed	2 / 61 (3.28%)	2 / 45 (4.44%)
occurrences all number	2	3
Dry skin
subjects affected / exposed	4 / 61 (6.56%)	2 / 45 (4.44%)
occurrences all number	4	2
Eczema
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Erythema
subjects affected / exposed	0 / 61 (0.00%)	4 / 45 (8.89%)
occurrences all number	0	4
Haemorrhage subcutaneous
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hair colour changes
subjects affected / exposed	0 / 61 (0.00%)	6 / 45 (13.33%)
occurrences all number	0	6
Hyperhidrosis
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	4
Hyperkeratosis
subjects affected / exposed	5 / 61 (8.20%)	1 / 45 (2.22%)
occurrences all number	9	1
Macule
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Madarosis
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Nail discolouration
subjects affected / exposed	3 / 61 (4.92%)	0 / 45 (0.00%)
occurrences all number	3	0
Nail disorder
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Night sweats
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Onycholysis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	19 / 61 (31.15%)	14 / 45 (31.11%)
occurrences all number	127	33
Pigmentation disorder
subjects affected / exposed	5 / 61 (8.20%)	1 / 45 (2.22%)
occurrences all number	6	1
Pruritus
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	1	4
Rash
subjects affected / exposed	7 / 61 (11.48%)	3 / 45 (6.67%)
occurrences all number	41	4
Skin discolouration
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Skin disorder
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	3	0
Skin exfoliation
subjects affected / exposed	8 / 61 (13.11%)	1 / 45 (2.22%)
occurrences all number	9	1
Skin fissures
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Skin hyperpigmentation
subjects affected / exposed	2 / 61 (3.28%)	2 / 45 (4.44%)
occurrences all number	2	2
Skin hypopigmentation
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Skin lesion
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Skin toxicity
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Swelling face
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	2
Vitiligo
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Yellow skin
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Dysuria
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Glycosuria
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Haematuria
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	5
Nephrolithiasis
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Proteinuria
subjects affected / exposed	5 / 61 (8.20%)	7 / 45 (15.56%)
occurrences all number	6	13
Renal colic
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Renal disorder
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Renal failure
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Endocrine disorders
Goitre
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Hypothyroidism
subjects affected / exposed	5 / 61 (8.20%)	3 / 45 (6.67%)
occurrences all number	6	8
Thyroid disorder
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	4 / 61 (6.56%)	4 / 45 (8.89%)
occurrences all number	10	9
Arthritis
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	2	1
Back pain
subjects affected / exposed	2 / 61 (3.28%)	6 / 45 (13.33%)
occurrences all number	2	6
Flank pain
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Joint effusion
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Joint swelling
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Limb discomfort
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Muscle spasms
subjects affected / exposed	4 / 61 (6.56%)	3 / 45 (6.67%)
occurrences all number	9	5
Muscular weakness
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Musculoskeletal chest pain
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Musculoskeletal pain
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Myalgia
subjects affected / exposed	3 / 61 (4.92%)	7 / 45 (15.56%)
occurrences all number	3	15
Myalgia intercostal
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Neck pain
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	2
Osteonecrosis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Pain in extremity
subjects affected / exposed	7 / 61 (11.48%)	2 / 45 (4.44%)
occurrences all number	11	2
Spinal osteoarthritis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Spinal pain
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Infections and infestations
Abdominal infection
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Bronchitis
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	2
Conjunctivitis
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	4
Cystitis
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	2	1
Enterocolitis infectious
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Fungal oesophagitis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Furuncle
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Gastroenteritis
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	2
Gastroenteritis viral
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	3
Gingival abscess
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Gingivitis
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	2	2
Hepatitis B
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Herpes zoster
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Influenza
subjects affected / exposed	1 / 61 (1.64%)	3 / 45 (6.67%)
occurrences all number	3	8
Lung infection
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Nasopharyngitis
subjects affected / exposed	6 / 61 (9.84%)	2 / 45 (4.44%)
occurrences all number	12	2
Oral candidiasis
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Oral herpes
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Parainfluenzae virus infection
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Paronychia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	2	0
Pharyngitis
subjects affected / exposed	2 / 61 (3.28%)	1 / 45 (2.22%)
occurrences all number	3	1
Pneumonia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Pulpitis dental
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Sinusitis
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Subcutaneous abscess
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Tinea versicolour
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	2
Tonsillitis
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Tooth abscess
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Upper respiratory tract infection
subjects affected / exposed	3 / 61 (4.92%)	2 / 45 (4.44%)
occurrences all number	5	3
Urinary tract infection
subjects affected / exposed	6 / 61 (9.84%)	2 / 45 (4.44%)
occurrences all number	7	2
Viral infection
subjects affected / exposed	1 / 61 (1.64%)	2 / 45 (4.44%)
occurrences all number	1	2
Vulvovaginal mycotic infection
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Respiratory tract infection
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	7 / 61 (11.48%)	7 / 45 (15.56%)
occurrences all number	21	7
Dehydration
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Diabetes mellitus
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Glucose tolerance impaired
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hypercalcaemia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	8	1
Hyperchloraemia
subjects affected / exposed	2 / 61 (3.28%)	0 / 45 (0.00%)
occurrences all number	2	0
Hypercholesterolaemia
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hypercreatininaemia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Hyperglycaemia
subjects affected / exposed	3 / 61 (4.92%)	3 / 45 (6.67%)
occurrences all number	6	3
Hyperkalaemia
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	3
Hypermagnesaemia
subjects affected / exposed	0 / 61 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1
Hypernatraemia
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Hypertriglyceridaemia
subjects affected / exposed	0 / 61 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	5
Hyperuricaemia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	2
Hypocalcaemia
subjects affected / exposed	2 / 61 (3.28%)	6 / 45 (13.33%)
occurrences all number	2	14
Hypochloraemia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Hypoglycaemia
subjects affected / exposed	2 / 61 (3.28%)	3 / 45 (6.67%)
occurrences all number	3	5
Hypokalaemia
subjects affected / exposed	7 / 61 (11.48%)	4 / 45 (8.89%)
occurrences all number	13	7
Hypomagnesaemia
subjects affected / exposed	5 / 61 (8.20%)	3 / 45 (6.67%)
occurrences all number	6	5
Hyponatraemia
subjects affected / exposed	2 / 61 (3.28%)	2 / 45 (4.44%)
occurrences all number	2	2
Hypophosphataemia
subjects affected / exposed	2 / 61 (3.28%)	7 / 45 (15.56%)
occurrences all number	5	9
Hypoproteinaemia
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	2
Iron deficiency
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Magnesium deficiency
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Malnutrition
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0
Vitamin B12 deficiency
subjects affected / exposed	1 / 61 (1.64%)	1 / 45 (2.22%)
occurrences all number	1	1
Vitamin D deficiency
subjects affected / exposed	1 / 61 (1.64%)	0 / 45 (0.00%)
occurrences all number	1	0

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Single-arm Open-label International Multi-center Study Of The Efficacy And Safety Of Sunitinib Malate (SU011248, Sutent (Registered)) In Patients With Progressive Advanced Metastatic Well-differentiated Unresectable Pancreatic Neuroendocrine Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Progression-Free Survival (PFS): Investigator Assessment

Primary: Progression-Free Survival (PFS): Investigator Assessment

Secondary: Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment

Secondary: Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment

Secondary: Time to Tumor Progression (TTP): Investigator Assessment

Secondary: Time to Tumor Progression (TTP): Investigator Assessment

Secondary: Overall Survival (OS)

Secondary: Overall Survival (OS)

Secondary: Percentage of Subjects With Objective Response (OR): Investigator Assessment

Secondary: Percentage of Subjects With Objective Response (OR): Investigator Assessment

Secondary: Duration of Response (DOR): Investigator Assessment

Secondary: Duration of Response (DOR): Investigator Assessment

Secondary: Time to Tumor Response (TTR): Investigator Assessment

Secondary: Time to Tumor Response (TTR): Investigator Assessment

Secondary: Percentage of Subjects With Objective Response: Independent Radiological Review (IRR) Assessment

Secondary: Percentage of Subjects With Objective Response: Independent Radiological Review (IRR) Assessment

Secondary: Duration of Response (DOR): Independent Radiological Review (IRR) Assessment

Secondary: Duration of Response (DOR): Independent Radiological Review (IRR) Assessment

Secondary: Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment

Secondary: Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment

Secondary: Percentage of Subjects With Chromogranin A (CgA) Response

Secondary: Percentage of Subjects With Chromogranin A (CgA) Response

Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)

Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)

Secondary: Plasma Concentration of Soluble Protein Biomarker (sKIT)

Secondary: Plasma Concentration of Soluble Protein Biomarker (sKIT)

Secondary: Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and its Metabolite SU012662

Secondary: Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and its Metabolite SU012662

Secondary: Dose-Corrected Trough Plasma Concentration of Sunitinib and its Metabolite SU012662

Secondary: Dose-Corrected Trough Plasma Concentration of Sunitinib and its Metabolite SU012662

Secondary: Area Under the Curve (AUC24) of Sunitinib and its Metabolite SU012662

Secondary: Area Under the Curve (AUC24) of Sunitinib and its Metabolite SU012662

Secondary: Oral Clearance (CL/F) of Sunitinib and its Metabolite SU012662

Secondary: Oral Clearance (CL/F) of Sunitinib and its Metabolite SU012662

Secondary: Half Maximal Effective Concentration (EC50) of Sunitinib

Secondary: Half Maximal Effective Concentration (EC50) of Sunitinib

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary: Number of Subjects With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary: Number of Subjects With Adverse Events (AEs) According to Severity

Secondary: Number of Subjects With Adverse Events (AEs) According to Severity

Secondary: Number of Subjects With Clinically Significant Laboratory Abnormalities

Secondary: Number of Subjects With Clinically Significant Laboratory Abnormalities

Secondary: Number of Subjects With Change From Baseline in Vital Signs Abnormalities

Secondary: Number of Subjects With Change From Baseline in Vital Signs Abnormalities

Secondary: Number of Subjects With Increase From Baseline in Corrected QT Interval (QTc)

Secondary: Number of Subjects With Increase From Baseline in Corrected QT Interval (QTc)

Secondary: Number of Subjects With Change From Baseline in Physical Examinations Findings

Secondary: Number of Subjects With Change From Baseline in Physical Examinations Findings

Secondary: Number of Subjects With Change From Baseline in Body Weight

Secondary: Number of Subjects With Change From Baseline in Body Weight

Secondary: Number of Subjects With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)

Secondary: Number of Subjects With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Single-arm Open-label International Multi-center Study Of The Efficacy And Safety Of Sunitinib Malate (SU011248, Sutent (Registered)) In Patients With Progressive Advanced Metastatic Well-differentiated Unresectable Pancreatic Neuroendocrine Tumors