Trial Outcomes & Findings for Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors (NCT NCT00372567)

NCT ID: NCT00372567

Last Updated: 2011-03-17

Results Overview

Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 69 participants
• Primary outcome timeframe: Baseline, Week 5, and every 8 weeks until Year 2
• Results posted on: 2011-03-17

Participant Flow

12 participants were enrolled in a lead-in Phase 1 safety sub-study, all of whom received Sunitinib 37.5 milligram (mg) 24 hours after the last dose of imatinib. No efficacy evaluations were planned/conducted for this sub-study.

Participant milestones

Measure	Sunitinib (Phase 3) Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.	Sunitinib (Phase 1) Single 37.5 mg dose administered 24 hours after the last dose of imatinib
Phase 1 Sub-study STARTED	0	0	12
Phase 1 Sub-study COMPLETED	0	0	12
Phase 1 Sub-study NOT COMPLETED	0	0	0
Phase 3 Study STARTED	31	26	12
Phase 3 Study Received Treatment	31	25	12
Phase 3 Study COMPLETED	0	0	0
Phase 3 Study NOT COMPLETED	31	26	12

Reasons for withdrawal

Measure	Sunitinib (Phase 3) Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.	Sunitinib (Phase 1) Single 37.5 mg dose administered 24 hours after the last dose of imatinib
Phase 3 Study Adverse Event	5	1	1
Phase 3 Study Death	1	1	0
Phase 3 Study Protocol Violation	0	0	1
Phase 3 Study Objective progression or relapse	10	13	4
Phase 3 Study Global deterioration of health status	0	1	0
Phase 3 Study Other	2	2	1
Phase 3 Study study terminated by sponsor	13	8	5

Baseline Characteristics

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

Baseline characteristics by cohort

Measure	Sunitinib (Phase 3) n=31 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=26 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.	Sunitinib (Phase 1) n=12 Participants Single 37.5 mg dose administered 24 hours after the last dose of imatinib	Total n=69 Participants Total of all reporting groups
Age, Customized less than 65 years	19 participants n=5 Participants	17 participants n=7 Participants	7 participants n=5 Participants	43 participants n=4 Participants
Age, Customized greater than or equal to 65 years	12 participants n=5 Participants	9 participants n=7 Participants	5 participants n=5 Participants	26 participants n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	42 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 5, and every 8 weeks until Year 2

Population: Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).

Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.

Outcome measures

Measure	Sunitinib n=13 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=15 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Progression-Free Survival (PFS)	8.6 Months Interval 5.7 to 9.0	6.4 Months Interval 4.5 to 15.7

SECONDARY outcome

Timeframe: Baseline up to 2 years

Population: ITT

Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.

Outcome measures

Measure	Sunitinib n=31 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=26 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Overall Survival (OS)	12.9 Months Interval 10.7 to 12.9	NA Months The estimate of median OS in the Imatinib Treatment Arm was not available (NA) because data was not mature.

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT

Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

Outcome measures

Measure	Sunitinib n=31 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=26 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Time to Pain Relief Response (TTPR)	34.0 Days Interval 11.0 to 57.0	22.0 Days Interval 8.0 to 113.0

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT; Number of participants analyzed: participants with treatment failure.

TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.

Outcome measures

Measure	Sunitinib n=16 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=17 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Time to Treatment Failure (TTF)	8.2 Months Interval 5.5 to 9.0	6.3 Months Interval 4.5 to 8.2

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT

Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Measure	Sunitinib n=31 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=26 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Number of Participants With Objective Response of Complete Response or Partial Response	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT

Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Measure	Sunitinib n=31 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=26 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Time to Tumor Response (TTR)	4.1 Weeks Interval 3.6 to 20.1	40.1 Weeks Interval 5.4 to 74.7

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.

Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.

Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Measure	Sunitinib n=5 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=2 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Duration of Response (DR)	18.3 Weeks Interval 7.9 to 24.1	19.8 Weeks Interval 6.7 to 32.9

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT; Number of participants analyzed: participants with an event.

TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

Outcome measures

Measure	Sunitinib n=14 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=10 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Time to Pain Progression (TTPP)	22.0 Days Interval 8.0 to 29.0	99.0 Days Interval 8.0 to 134.0

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.

Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

Outcome measures

Measure	Sunitinib n=7 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=10 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Number of Participants With Pain Relief Response	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 28 of Cycle 1 up to 26

Population: ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.

Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.

Outcome measures

Measure	Sunitinib n=23 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib n=21 Participants Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Number of Participants With Pain Progression	14 Participants	10 Participants

SECONDARY outcome

Timeframe: Days 1 and 28 of each cycle

Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.

Outcome measures

Measure	Sunitinib n=30 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 10 (n=5)	0.78 Scores on a scale Standard Deviation 0.128	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 11 (n=3)	0.83 Scores on a scale Standard Deviation 0.157	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 12 (n=2)	0.93 Scores on a scale Standard Deviation 0.106	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 1 (n=30)	0.90 Scores on a scale Standard Deviation 0.159	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 2 (n=27)	0.84 Scores on a scale Standard Deviation 0.196	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 3 (n=21)	0.84 Scores on a scale Standard Deviation 0.130	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 4 (n=23)	0.85 Scores on a scale Standard Deviation 0.186	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 5 (n=16)	0.89 Scores on a scale Standard Deviation 0.133	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 6 (n=16)	0.90 Scores on a scale Standard Deviation 0.120	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 7 (n=12)	0.84 Scores on a scale Standard Deviation 0.182	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 8 (n=11)	0.83 Scores on a scale Standard Deviation 0.168	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm Cycle 9 (n=6)	0.76 Scores on a scale Standard Deviation 0.149	—

SECONDARY outcome

Timeframe: Days 1 and 28 of each cycle

Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.

EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.

Outcome measures

Measure	Sunitinib n=30 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 1 (n=30)	78.13 Scores on a Scale Standard Deviation 23.80	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 2 (n=27)	77.19 Scores on a Scale Standard Deviation 19.98	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 3 (n=21)	78.52 Scores on a Scale Standard Deviation 14.24	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 4 (n=23)	80.17 Scores on a Scale Standard Deviation 14.28	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 5 (n=16)	84.25 Scores on a Scale Standard Deviation 12.30	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 6 (n=16)	85.81 Scores on a Scale Standard Deviation 13.25	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 7 (n=12)	78.25 Scores on a Scale Standard Deviation 15.91	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 8 (n=11)	84.73 Scores on a Scale Standard Deviation 12.71	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 9 (n=7)	82.57 Scores on a Scale Standard Deviation 14.30	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 10 (n=6)	81.00 Scores on a Scale Standard Deviation 12.59	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 11 (n=3)	81.00 Scores on a Scale Standard Deviation 14.93	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm Cycle 12 (n=2)	86.50 Scores on a Scale Standard Deviation 16.26	—

SECONDARY outcome

Timeframe: Days 1 and 28 of each cycle

Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.

EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.

Outcome measures

Measure	Sunitinib n=23 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 1 (n=22)	0.80 Scores on a scale Standard Deviation 0.117	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 2 (n=23)	0.85 Scores on a scale Standard Deviation 0.135	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 3 (n=18)	0.82 Scores on a scale Standard Deviation 0.162	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 4 (n=18)	0.86 Scores on a scale Standard Deviation 0.143	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 5 (n=17)	0.83 Scores on a scale Standard Deviation 0.217	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 6 (n=12)	0.84 Scores on a scale Standard Deviation 0.157	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 7 (n=12)	0.81 Scores on a scale Standard Deviation 0.260	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 8 ( (n=11)	0.68 Scores on a scale Standard Deviation 0.292	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 9 (n=7)	0.86 Scores on a scale Standard Deviation 0.105	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 10 (n=7)	0.86 Scores on a scale Standard Deviation 0.104	—
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm Cycle 11 (n=3)	0.88 Scores on a scale Standard Deviation 0.106	—

SECONDARY outcome

Timeframe: Days 1 and 28 of each cycle

Population: ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.

EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.

Outcome measures

Measure	Sunitinib n=22 Participants Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.	Imatinib Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 1 (n=22)	75.41 Scores on a scale Standard Deviation 16.60	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 2 (n=22)	73.64 Scores on a scale Standard Deviation 14.61	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 3 (n=20)	72.85 Scores on a scale Standard Deviation 15.24	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 4 (n=18)	76.14 Scores on a scale Standard Deviation 15.78	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 5 (n=15)	68.93 Scores on a scale Standard Deviation 12.82	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 6 (n=11)	68.27 Scores on a scale Standard Deviation 15.10	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 7 (n=12)	67.08 Scores on a scale Standard Deviation 18.08	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 8 (n=10)	63.70 Scores on a scale Standard Deviation 19.23	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 9 (n=7)	74.64 Scores on a scale Standard Deviation 13.26	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 10 (n=7)	76.86 Scores on a scale Standard Deviation 8.009	—
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm Cycle 11 (n=3)	75.33 Scores on a scale Standard Deviation 5.508	—

Adverse Events

All Participants Who Received Sunitinib

Serious events: 11 serious events

Other events: 43 other events

Deaths: 0 deaths

Imatinib

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants Who Received Sunitinib n=43 participants at risk Participants in Phase 1 sub- study and Phase 3 study	Imatinib n=25 participants at risk All participants who received Imatinib
Cardiac disorders Myocardial infarction	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Cardiac disorders Tachycardia	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Abdominal distension	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Abdominal pain	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Constipation	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Diarrhoea	4.7% 2/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Intestinal obstruction	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Nausea	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Peritonitis	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Rectal haemorrhage	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Vomiting	4.7% 2/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Disease progression	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Pyrexia	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Infections and infestations Lower respiratory tract infection	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Infections and infestations Lung infection	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Infections and infestations Pyelonephritis	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Investigations Haemoglobin decreased	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Nervous system disorders Sciatica	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Renal and urinary disorders Renal impairment	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.

Other adverse events

Measure	All Participants Who Received Sunitinib n=43 participants at risk Participants in Phase 1 sub- study and Phase 3 study	Imatinib n=25 participants at risk All participants who received Imatinib
Blood and lymphatic system disorders Anaemia	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Blood and lymphatic system disorders Neutropenia	20.9% 9/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Blood and lymphatic system disorders Thrombocytopenia	18.6% 8/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Endocrine disorders Hypothyroidism	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Eye disorders Eyelid oedema	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Eye disorders Lacrimation increased	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Abdominal discomfort	4.7% 2/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	12.0% 3/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Abdominal distension	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	16.0% 4/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Abdominal pain	14.0% 6/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	12.0% 3/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Abdominal pain upper	9.3% 4/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	12.0% 3/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Constipation	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	16.0% 4/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Diarrhoea	44.2% 19/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	32.0% 8/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Dyspepsia	14.0% 6/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Flatulence	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Glossodynia	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Nausea	27.9% 12/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	36.0% 9/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Oral pain	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Stomatitis	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Gastrointestinal disorders Vomiting	14.0% 6/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	24.0% 6/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Asthenia	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Face oedema	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Fatigue	30.2% 13/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	32.0% 8/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Feeling cold	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Mucosal inflammation	34.9% 15/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Oedema	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	20.0% 5/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Oedema peripheral	9.3% 4/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	20.0% 5/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
General disorders Pyrexia	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Infections and infestations Upper respiratory tract infection	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Investigations Electrocardiogram QT prolonged	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Metabolism and nutrition disorders Decreased appetite	16.3% 7/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	12.0% 3/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Musculoskeletal and connective tissue disorders Myalgia	11.6% 5/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Nervous system disorders Dysgeusia	20.9% 9/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Nervous system disorders Headache	14.0% 6/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Nervous system disorders Lethargy	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Psychiatric disorders Insomnia	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Respiratory, thoracic and mediastinal disorders Cough	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	8.0% 2/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	12.0% 3/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Alopecia	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Blister	9.3% 4/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Dry skin	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	12.0% 3/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Hair colour changes	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	37.2% 16/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Periorbital oedema	0.00% 0/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	16.0% 4/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Pruritus	2.3% 1/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	16.0% 4/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Rash	18.6% 8/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	16.0% 4/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Skin and subcutaneous tissue disorders Yellow skin	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Vascular disorders Flushing	7.0% 3/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	4.0% 1/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.
Vascular disorders Hypertension	37.2% 16/43 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.	0.00% 0/25 The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. One participant enrolled in the imatinib arm was inadvertently randomized (participant did not meet inclusion criteria) and was not treated in this study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER