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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

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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

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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