Trial Outcomes & Findings for A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST) (NCT NCT00075218)

Last Updated: 2009-09-28

Results Overview

Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

361 participants

Primary outcome timeframe

Day 28 of each 6-week cycle : duration of double-blind treatment phase

Results posted on

2009-09-28

Participant Flow

Enrollment began (medical clinic) in December 2003. Study was unblinded on 27 January 2005 (end of Double-blind treatment). Subjects experiencing disease progression could crossover to Open-label treatment. Open-label data collection ended May 2008.

361 subjects randomized to double-blind treatment in 2:1 ratio (sunitinib vs. Placebo). 255 subjects continued on or crossed over to Open-label treatment.

Participant milestones

Participant milestones
Measure	Sunitinib Double-Blind Treatment Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.	Sunitinib Open-Label Treatment Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
Double-Blind Treatment STARTED	243	118	0
Double-Blind Treatment Received Double-Blind Treatment	228	114	0
Double-Blind Treatment Crossed Over to Open-Label Treatment	152	103	0
Double-Blind Treatment COMPLETED	152	103	0
Double-Blind Treatment NOT COMPLETED	91	15	0
Open-Label Treatment STARTED	0	0	255
Open-Label Treatment COMPLETED	0	0	0
Open-Label Treatment NOT COMPLETED	0	0	255

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Double-Blind Treatment Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.	Sunitinib Open-Label Treatment Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
Double-Blind Treatment Adverse Event	23	4	0
Double-Blind Treatment Withdrawal by Subject	7	4	0
Double-Blind Treatment Lost to Follow-up	1	0	0
Double-Blind Treatment Lack of Efficacy	58	6	0
Double-Blind Treatment Decision of Sponsor	0	1	0
Double-Blind Treatment No study medication taken	2	0	0
Open-Label Treatment Lack of Efficacy	0	0	174
Open-Label Treatment Adverse Event	0	0	51
Open-Label Treatment Withdrawal by Subject	0	0	12
Open-Label Treatment Decision of Sponsor	0	0	8
Open-Label Treatment Protocol Violation	0	0	1
Open-Label Treatment enrolled in a separate continuation	0	0	9

Baseline Characteristics

A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.	Total n=361 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	170 Participants n=5 Participants	81 Participants n=7 Participants	251.0 Participants n=5 Participants
Age, Categorical >=65 years	73 Participants n=5 Participants	37 Participants n=7 Participants	110.0 Participants n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	71 Participants n=7 Participants	162.0 Participants n=5 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	47 Participants n=7 Participants	199.0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 of each 6-week cycle : duration of double-blind treatment phase

Population: From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=207 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=105 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase	27.3 weeks Interval 16.0 to 32.1	6.4 weeks Interval 4.4 to 10.0

PRIMARY outcome

Timeframe: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)

Population: From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study	26.6 weeks Interval 16.0 to 32.1	6.4 weeks Interval 4.4 to 10.0

SECONDARY outcome

Timeframe: Day 28 of each cycle : duration of double-blind treatment phase

Population: ITT population

Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Progression Free Survival (PFS)	22.9 weeks Interval 10.9 to 28.0	6.0 weeks Interval 4.4 to 9.7

SECONDARY outcome

Timeframe: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug

Population: ITT population.

Number of subjects alive at end of study.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Overall Survival Status of Subjects Dead	176 participants	90 participants
Overall Survival Status of Subjects Alive	67 participants	28 participants

SECONDARY outcome

Timeframe: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug

Population: ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.

Time from date of randomization to date of death due to any cause.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Overall Survival	72.7 weeks Interval 61.3 to 83.0	64.9 weeks Interval 45.7 to 96.0

SECONDARY outcome

Timeframe: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug

Population: ITT population

time from date of randomization to date of death due to any cause (rank preserving structural failure time method).

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Overall Survival Based on the Rank Preserving Structural Failure Time Method	72.7 weeks Interval 61.3 to 83.0	39.0 weeks Interval 28.0 to 54.1

SECONDARY outcome

Timeframe: Day 28 of each cycle : duration of double-blind treatment phase

Population: ITT population

Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Best Overall Tumor Response During Double-blind Treatment Phase Complete Response (CR)	0 participants	0 participants
Best Overall Tumor Response During Double-blind Treatment Phase Partial Response (PR)	16 participants	0 participants
Best Overall Tumor Response During Double-blind Treatment Phase Stable Disease	128 participants	50 participants
Best Overall Tumor Response During Double-blind Treatment Phase Progressive Disease	45 participants	44 participants
Best Overall Tumor Response During Double-blind Treatment Phase Unable to Evaluate	1 participants	0 participants
Best Overall Tumor Response During Double-blind Treatment Phase Missing	53 participants	24 participants

SECONDARY outcome

Timeframe: Day 28 of each cycle : duration of double-blind treatment phase

Population: ITT population.

Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Confirmed Objective Response (CR or PR) in Subjects	16 participants	0 participants

SECONDARY outcome

Timeframe: Day 28 of each cycle : duration of double-blind treatment phase

Population: ITT population. Number of subjects analyzed = number of subjects with tumor response.

Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=16 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Time to Tumor Response (TTR)	13.4 weeks Interval 9.9 to 16.1	—

SECONDARY outcome

Timeframe: Day 28 of each cycle : duration of double-blind treatment phase

Population: ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.

Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=106 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Duration of Performance Status Maintenance	18.9 weeks Interval 12.1 to 31.1	—

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle : duration of double-blind treatment phase

Population: Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.

25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use \>= 50% over baseline OR b) Increase score \>= 1 point with either NC in total analgesic use or increase total analgesic use \>= 50% over baseline. (50th Quartile not achieved.)

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=37 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)	12.1 weeks (25th Quartile) Interval 6.1 to 27.1	—

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle : duration of double-blind treatment phase

Population: Pain-Relief-Response population.

MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by \>= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use \>= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use \>= 50% over baseline.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=150 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=75 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)	46 participants	10 participants

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle : duration of double-blind treatment phase

Population: ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)

Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Cycle 1 Day 28 (n=187, 89)	-3.0 score on scale Interval -60.0 to 70.0	0.0 score on scale Interval -50.0 to 45.0
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Cycle 2 Day 1 (n=148, 53)	0.0 score on scale Interval -60.0 to 55.0	0.0 score on scale Interval -30.0 to 41.0
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Cycle 2 Day 28 (n=132, 41)	-4.5 score on scale Interval -50.0 to 55.0	0.0 score on scale Interval -80.0 to 40.0
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Cycle 3 Day 1 (n=102,16)	0.0 score on scale Interval -58.0 to 32.0	0.0 score on scale Interval -75.0 to 34.0
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Cycle 3 Day 28 (n=91,13)	-5.0 score on scale Interval -55.0 to 42.0	-1.0 score on scale Interval -75.0 to 16.0
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) Cycle 4 Day 1 (n=73,10)	0.0 score on scale Interval -65.0 to 40.0	5.0 score on scale Interval -10.0 to 15.0

SECONDARY outcome

Timeframe: Day 1 & 28 of each cycle : duration of double-blind treatment phase

Population: ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)

Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.

Outcome measures

Outcome measures
Measure	Sunitinib Double-Blind Treatment n=243 Participants Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment n=118 Participants Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
Change From Baseline in EQ-5D Health State Profile Index Cycle 1 Day 28 (n=185, 87)	0.000 score on scale Interval -1.008 to 0.736	0.000 score on scale Interval -0.655 to 0.532
Change From Baseline in EQ-5D Health State Profile Index Cycle 2 Day 1 (n=149, 53)	0.000 score on scale Interval -1.244 to 0.603	0.000 score on scale Interval -0.603 to 0.434
Change From Baseline in EQ-5D Health State Profile Index Cycle 2 Day 28 (n=129, 41)	-0.017 score on scale Interval -1.008 to 0.603	0.000 score on scale Interval -0.694 to 0.655
Change From Baseline in EQ-5D Health State Profile Index Cycle 3 Day 1 (n=104, 17)	0.000 score on scale Interval -0.694 to 0.639	0.000 score on scale Interval -0.655 to 0.192
Change From Baseline in EQ-5D Health State Profile Index Cycle 3 Day 28 (n=91, 13)	-0.036 score on scale Interval -1.175 to 0.736	0.000 score on scale Interval -0.655 to 0.204
Change From Baseline in EQ-5D Health State Profile Index Cycle 4 Day 1 (n=74, 10)	0.000 score on scale Interval -0.768 to 0.603	0.059 score on scale Interval -0.152 to 0.275

Adverse Events

Sunitinib Double-Blind Treatment

Serious events: 83 serious events

Other events: 223 other events

Deaths: 0 deaths

Placebo Double-Blind Treatment

Serious events: 27 serious events

Other events: 110 other events

Deaths: 0 deaths

Sunitinib Open-Label Treatment

Serious events: 122 serious events

Other events: 254 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib Double-Blind Treatment Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.	Sunitinib Open-Label Treatment Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
Blood and lymphatic system disorders Anaemia	4.8% 11/228	0.88% 1/114	3.9% 10/255
Blood and lymphatic system disorders Thrombocytopenia	2.2% 5/228	0.00% 0/114	1.6% 4/255
Blood and lymphatic system disorders Neutropenia	0.88% 2/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders Febrile neutropenia	0.44% 1/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders Leukopenia	0.44% 1/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Cardiac arrest	0.44% 1/228	0.88% 1/114	0.00% 0/255
Cardiac disorders Cardiac disorder	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Cardiac failure	0.44% 1/228	0.88% 1/114	0.00% 0/255
Cardiac disorders Cardiomyopathy	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Ejection fraction decreased	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Left ventricular failure	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Mitral valve imcompetence	0.44% 1/228	0.00% 0/114	0.00% 0/255
Congenital, familial and genetic disorders Pyloric stenosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Endocrine disorders Hypothyroidism	0.44% 1/228	0.00% 0/114	1.6% 4/255
Gastrointestinal disorders Abdominal pain	5.7% 13/228	5.3% 6/114	11.4% 29/255
Gastrointestinal disorders Nausea	2.2% 5/228	2.6% 3/114	3.1% 8/255
Gastrointestinal disorders Vomiting	2.2% 5/228	3.5% 4/114	4.7% 12/255
Gastrointestinal disorders Ascites	1.8% 4/228	0.88% 1/114	1.2% 3/255
Gastrointestinal disorders Diarrhoea	1.8% 4/228	0.00% 0/114	1.6% 4/255
Gastrointestinal disorders Abdominal distension	0.88% 2/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Constipation	0.88% 2/228	0.88% 1/114	2.0% 5/255
Gastrointestinal disorders Gastrointestinal haemorrhage	0.88% 2/228	2.6% 3/114	1.6% 4/255
Gastrointestinal disorders Intestinal obstruction	0.88% 2/228	0.88% 1/114	0.78% 2/255
Gastrointestinal disorders Melaena	0.88% 2/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Abdominal pain upper	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Anal fistula	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastric haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastric ulcer	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastritis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastritis haemorrhagic	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastrointestinal obstruction	0.44% 1/228	0.88% 1/114	0.00% 0/255
Gastrointestinal disorders Haematemesis	0.44% 1/228	0.88% 1/114	1.2% 3/255
Gastrointestinal disorders Haemorrhoids	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Intestinal haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Oesophageal haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Rectal haemorrhage	0.44% 1/228	0.88% 1/114	2.0% 5/255
Gastrointestinal disorders Small intestinal obstruction	0.44% 1/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Ileus	0.00% 0/228	1.8% 2/114	0.78% 2/255
Gastrointestinal disorders Subileus	0.00% 0/228	0.88% 1/114	0.39% 1/255
General disorders Disease progression	3.5% 8/228	3.5% 4/114	12.9% 33/255
General disorders Pyrexia	3.5% 8/228	0.88% 1/114	4.3% 11/255
General disorders Fatigue	0.88% 2/228	0.88% 1/114	1.2% 3/255
General disorders Oedema peripheral	0.88% 2/228	0.00% 0/114	0.00% 0/255
General disorders Asthenia	0.44% 1/228	0.88% 1/114	1.2% 3/255
General disorders Chills	0.44% 1/228	0.00% 0/114	0.78% 2/255
General disorders Drug interaction	0.44% 1/228	0.00% 0/114	0.00% 0/255
General disorders General physical health deterioration	0.44% 1/228	2.6% 3/114	1.6% 4/255
General disorders Multi-organ failure	0.44% 1/228	0.00% 0/114	0.39% 1/255
General disorders Oedema	0.44% 1/228	0.00% 0/114	0.00% 0/255
General disorders Chest pain	0.00% 0/228	0.88% 1/114	1.2% 3/255
Hepatobiliary disorders Acute hepatic failure	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Bile duct stone	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Cholecystitis acute	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Cholelithiasis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Cholestasis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Hepatic failure	0.44% 1/228	0.00% 0/114	0.78% 2/255
Hepatobiliary disorders Hepatic function abnormal	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Hepatic haemorrhage	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Catheter sepsis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Central line infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Infection	0.44% 1/228	0.00% 0/114	1.2% 3/255
Infections and infestations Mediastinitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Pneumonia	0.44% 1/228	0.88% 1/114	1.6% 4/255
Infections and infestations Staphylococcal sepsis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Urinary tract infection	0.44% 1/228	0.00% 0/114	0.78% 2/255
Infections and infestations Viral infection	0.44% 1/228	0.88% 1/114	0.00% 0/255
Infections and infestations Bacteraemia	0.00% 0/228	0.88% 1/114	0.78% 2/255
Infections and infestations Cystitis	0.00% 0/228	0.88% 1/114	0.00% 0/255
Infections and infestations Lower respiratory tract infection	0.00% 0/228	0.88% 1/114	0.39% 1/255
Injury, poisoning and procedural complications Wound dehiscence	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Aspartate aminotransferase increased	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Blood creatinine increased	0.44% 1/228	0.00% 0/114	1.2% 3/255
Investigations Haemoglobin decreased	0.44% 1/228	0.88% 1/114	0.78% 2/255
Metabolism and nutrition disorders Dehydration	1.8% 4/228	0.00% 0/114	3.9% 10/255
Metabolism and nutrition disorders Hypoglycaemia	1.8% 4/228	0.00% 0/114	0.00% 0/255
Metabolism and nutrition disorders Food intolerance	0.44% 1/228	0.00% 0/114	0.00% 0/255
Metabolism and nutrition disorders Hypercalcaemia	0.44% 1/228	0.88% 1/114	0.39% 1/255
Metabolism and nutrition disorders Hypocalcaemia	0.44% 1/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Hypokalaemia	0.44% 1/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Anorexia	0.00% 0/228	0.88% 1/114	1.2% 3/255
Metabolism and nutrition disorders Appetite disorder	0.00% 0/228	0.88% 1/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Back pain	0.44% 1/228	1.8% 2/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Fistula	0.44% 1/228	0.00% 0/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Flank pain	0.44% 1/228	0.00% 0/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Muscle spasms	0.44% 1/228	0.00% 0/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Pain in extremity	0.44% 1/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/228	0.88% 1/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/228	0.88% 1/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/228	0.88% 1/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.3% 3/228	0.00% 0/114	1.2% 3/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemorrhagic tumour necrosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour lysis syndrome	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/228	0.88% 1/114	0.00% 0/255
Nervous system disorders Cerebral ischaemia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Encephalopathy	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Myoclonus	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Somnolence	0.44% 1/228	0.00% 0/114	0.78% 2/255
Nervous system disorders Syncope	0.44% 1/228	0.00% 0/114	1.2% 3/255
Nervous system disorders Transient ischaemic attack	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Cerebrovascular accident	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Paralysis	0.00% 0/228	0.88% 1/114	0.00% 0/255
Psychiatric disorders Insomnia	0.00% 0/228	0.88% 1/114	0.00% 0/255
Psychiatric disorders Nervousness	0.00% 0/228	0.88% 1/114	0.00% 0/255
Renal and urinary disorders Haematuria	0.44% 1/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Nephrotic syndrome	0.44% 1/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Oliguria	0.44% 1/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Renal colic	0.44% 1/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Renal failure acute	0.44% 1/228	0.88% 1/114	0.39% 1/255
Renal and urinary disorders Urinary retention	0.44% 1/228	0.00% 0/114	0.78% 2/255
Renal and urinary disorders Hydronephrosis	0.00% 0/228	0.88% 1/114	0.00% 0/255
Reproductive system and breast disorders Pelvic pain	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 4/228	0.88% 1/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.44% 1/228	0.00% 0/114	0.00% 0/255
Skin and subcutaneous tissue disorders Rash	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Deep vein thrombosis	0.44% 1/228	0.00% 0/114	1.2% 3/255
Vascular disorders Haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Hypertensive crisis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Thrombosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Circulatory collapse	0.00% 0/228	0.88% 1/114	0.00% 0/255
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders Lymphopenia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Cardio-respiratory arrest	0.00% 0/228	0.00% 0/114	0.78% 2/255
Cardiac disorders Angina pectoris	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Bradycardia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Cardiac failure congestive	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Myocardial infarction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Pericardial effusion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Ventricular hypokinesia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Congenital, familial and genetic disorders Epidermolysis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Abdominal discomfort	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Anal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Duodenal fistula	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Duodenal ulcer	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Dyspepsia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Inguinal hernia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Performance status decreased	0.00% 0/228	0.00% 0/114	0.78% 2/255
General disorders Catheter related complication	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Impaired healing	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Infusion site extravasation	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Mucosal inflammation	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Pain	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Pneumatosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Ulcer haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Cholecystitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Hepatotoxicity	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Gastroenteritis	0.00% 0/228	0.00% 0/114	0.78% 2/255
Infections and infestations Abdominal abscess	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Bacterial infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Campylobacter infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Cellulitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Empyema	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Gastrointestinal infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Liver abscess	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Perirectal abscess	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Respiratory tract infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Sepsis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Urosepsis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Device malfunction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Feeding tube complication	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Medication error	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Neck injury	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Skin laceration	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Ammonia increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood bilirubin increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood creatine phosphokinase increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood potassium decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood pressure increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Weight decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Cachexia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/228	0.00% 0/114	1.2% 3/255
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma benign	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour perforation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Hepatic encephalopathy	0.00% 0/228	0.00% 0/114	1.2% 3/255
Nervous system disorders Lethargy	0.00% 0/228	0.00% 0/114	1.2% 3/255
Nervous system disorders Cerebral haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Coma	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Convulsion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Dizziness	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Guillain-Barre syndrome	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Intracranial venous sinus thrombosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Lacunar infarction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Loss of consciousness	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Paraesthesia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Confusional state	0.00% 0/228	0.00% 0/114	1.6% 4/255
Psychiatric disorders Agitation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Completed suicide	0.00% 0/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Renal failure	0.00% 0/228	0.00% 0/114	0.78% 2/255
Renal and urinary disorders Renal impairment	0.00% 0/228	0.00% 0/114	0.78% 2/255
Renal and urinary disorders Dysuria	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Uterine polyp	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/228	0.00% 0/114	1.2% 3/255
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/228	0.00% 0/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/228	0.00% 0/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Hepatic embolisation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Stent placement	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Hypertension	0.00% 0/228	0.00% 0/114	1.6% 4/255
Vascular disorders Hypotension	0.00% 0/228	0.00% 0/114	1.2% 3/255
Vascular disorders Thrombophlebitis	0.00% 0/228	0.00% 0/114	0.78% 2/255
Vascular disorders Embolism	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Jugular vein thrombosis	0.00% 0/228	0.00% 0/114	0.39% 1/255

Other adverse events

Other adverse events
Measure	Sunitinib Double-Blind Treatment Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.	Placebo Double-Blind Treatment Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.	Sunitinib Open-Label Treatment Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour lysis syndrome	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.44% 1/228	0.00% 0/114	2.4% 6/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vascular neoplasm	0.44% 1/228	0.00% 0/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/228	0.88% 1/114	0.00% 0/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Dysgeusia	23.7% 54/228	2.6% 3/114	22.4% 57/255
Nervous system disorders Headache	21.1% 48/228	15.8% 18/114	26.3% 67/255
Nervous system disorders Dizziness	9.6% 22/228	6.1% 7/114	12.2% 31/255
Nervous system disorders Paraesthesia	4.8% 11/228	0.88% 1/114	6.3% 16/255
Nervous system disorders Hypoaesthesia	3.5% 8/228	3.5% 4/114	4.7% 12/255
Nervous system disorders Neuropathy peripheral	3.1% 7/228	1.8% 2/114	3.1% 8/255
Nervous system disorders Ageusia	2.6% 6/228	0.00% 0/114	2.0% 5/255
Nervous system disorders Peripheral sensory neuropathy	2.2% 5/228	1.8% 2/114	2.0% 5/255
Nervous system disorders Sciatica	1.8% 4/228	0.00% 0/114	1.2% 3/255
Nervous system disorders Somnolence	1.8% 4/228	1.8% 2/114	3.5% 9/255
Nervous system disorders Balance disorder	1.3% 3/228	0.88% 1/114	0.00% 0/255
Nervous system disorders Hyperaesthesia	1.3% 3/228	0.88% 1/114	1.2% 3/255
Nervous system disorders Lethargy	1.3% 3/228	0.88% 1/114	3.5% 9/255
Nervous system disorders Syncope	1.3% 3/228	0.88% 1/114	1.2% 3/255
Nervous system disorders Tremor	1.3% 3/228	0.88% 1/114	2.0% 5/255
Nervous system disorders Dizziness postural	0.88% 2/228	0.00% 0/114	0.78% 2/255
Nervous system disorders Memory impairment	0.88% 2/228	0.88% 1/114	1.6% 4/255
Nervous system disorders Migraine	0.88% 2/228	0.00% 0/114	1.2% 3/255
Nervous system disorders Parosmia	0.88% 2/228	0.88% 1/114	0.00% 0/255
Nervous system disorders Sinus headache	0.88% 2/228	0.88% 1/114	2.0% 5/255
Nervous system disorders Amnesia	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Ataxia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Cerebral ischaemia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Depressed level of consciousness	0.44% 1/228	0.00% 0/114	0.78% 2/255
Nervous system disorders Diabetic neuropathy	0.44% 1/228	0.00% 0/114	0.78% 2/255
Nervous system disorders Disturbance in attention	0.44% 1/228	0.88% 1/114	0.78% 2/255
Nervous system disorders Encephalopathy	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Facial palsy	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Head discomfort	0.44% 1/228	0.00% 0/114	0.00% 0/255
Nervous system disorders Myoclonus	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Peripheral motor neuropathy	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Restless legs syndrome	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Sensory disturbance	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Syncope vasovagal	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Transient ischaemic attack	0.44% 1/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Burning sensation	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Cerebrovascular accident	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Coma	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Hemicephalalgia	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Neuralgia	0.00% 0/228	0.88% 1/114	0.39% 1/255
Nervous system disorders Paralysis	0.00% 0/228	0.88% 1/114	0.00% 0/255
Psychiatric disorders Insomnia	11.0% 25/228	9.6% 11/114	13.3% 34/255
Psychiatric disorders Anxiety	3.1% 7/228	1.8% 2/114	4.3% 11/255
Psychiatric disorders Depression	3.1% 7/228	1.8% 2/114	9.0% 23/255
Psychiatric disorders Agitation	0.88% 2/228	0.88% 1/114	2.7% 7/255
Psychiatric disorders Confusional state	0.88% 2/228	1.8% 2/114	5.5% 14/255
Psychiatric disorders Nervousness	0.44% 1/228	0.88% 1/114	0.78% 2/255
Psychiatric disorders Sleep disorder	0.44% 1/228	0.00% 0/114	0.00% 0/255
Psychiatric disorders Depressed mood	0.00% 0/228	0.88% 1/114	0.39% 1/255
Blood and lymphatic system disorders Anaemia	20.2% 46/228	8.8% 10/114	31.4% 80/255
Blood and lymphatic system disorders Neutropenia	14.5% 33/228	0.88% 1/114	25.1% 64/255
Blood and lymphatic system disorders Thrombocytopenia	14.5% 33/228	0.88% 1/114	17.3% 44/255
Blood and lymphatic system disorders Leukopenia	4.8% 11/228	0.88% 1/114	8.6% 22/255
Blood and lymphatic system disorders Lymphopenia	0.88% 2/228	0.88% 1/114	3.5% 9/255
Blood and lymphatic system disorders Febrile neutropenia	0.44% 1/228	0.00% 0/114	0.78% 2/255
Blood and lymphatic system disorders Hand and foot syndrome secondary to sickle cell anaemia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Blood and lymphatic system disorders Lymphadenopathy	0.44% 1/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders Pancytopenia	0.44% 1/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Ejection fraction decreased	8.3% 19/228	2.6% 3/114	2.0% 5/255
Cardiac disorders Left ventricular dysfunction	1.8% 4/228	0.88% 1/114	2.4% 6/255
Cardiac disorders Tachycardia	1.3% 3/228	0.00% 0/114	1.6% 4/255
Cardiac disorders Bradycardia	0.88% 2/228	0.00% 0/114	1.2% 3/255
Cardiac disorders Cardiac disorder	0.88% 2/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Cardiomyopathy	0.88% 2/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Palpitations	0.88% 2/228	1.8% 2/114	0.78% 2/255
Cardiac disorders Angina pectoris	0.44% 1/228	0.00% 0/114	1.2% 3/255
Cardiac disorders Arrhythmia supraventricular	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Atrial fibrillation	0.44% 1/228	0.88% 1/114	0.39% 1/255
Cardiac disorders Cardiac arrest	0.44% 1/228	0.88% 1/114	0.00% 0/255
Cardiac disorders Cardiac failure	0.44% 1/228	0.88% 1/114	0.39% 1/255
Cardiac disorders Cardiomegaly	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Electrocardiogram QT prolonged	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Left atrial dilatation	0.44% 1/228	0.88% 1/114	0.39% 1/255
Cardiac disorders Left ventricular failure	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Mitral valve incompetence	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Pericardial effusion	0.44% 1/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Sinus arrhythmia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Ventricular extrasystoles	0.44% 1/228	0.00% 0/114	0.00% 0/255
Cardiac disorders Bundle branch block left	0.00% 0/228	0.88% 1/114	0.00% 0/255
Cardiac disorders Sinus tachycardia	0.00% 0/228	0.88% 1/114	0.00% 0/255
Congenital, familial and genetic disorders Pyloric stenosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Ear and labyrinth disorders Ear discomfort	0.44% 1/228	0.00% 0/114	0.78% 2/255
Ear and labyrinth disorders Ear pain	0.44% 1/228	0.88% 1/114	1.2% 3/255
Ear and labyrinth disorders Hypoacusis	0.44% 1/228	0.00% 0/114	0.39% 1/255
Ear and labyrinth disorders Vertigo	0.44% 1/228	0.88% 1/114	0.39% 1/255
Ear and labyrinth disorders Tinnitus	0.00% 0/228	0.88% 1/114	1.2% 3/255
Endocrine disorders Hypothyroidism	3.9% 9/228	0.88% 1/114	17.6% 45/255
Endocrine disorders Adrenal insufficiency	0.44% 1/228	0.00% 0/114	0.39% 1/255
Endocrine disorders Cushingoid	0.44% 1/228	0.00% 0/114	0.00% 0/255
Eye disorders Eye oedema	2.2% 5/228	0.00% 0/114	2.0% 5/255
Eye disorders Lacrimation increased	1.8% 4/228	0.88% 1/114	0.78% 2/255
Eye disorders Vision blurred	1.3% 3/228	0.88% 1/114	2.0% 5/255
Eye disorders Conjunctival haemorrhage	0.88% 2/228	0.00% 0/114	0.00% 0/255
Eye disorders Conjunctivitis	0.88% 2/228	1.8% 2/114	2.4% 6/255
Eye disorders Visual disturbance	0.88% 2/228	0.00% 0/114	1.6% 4/255
Eye disorders Diplopia	0.44% 1/228	1.8% 2/114	0.00% 0/255
Eye disorders Eyelid oedema	0.44% 1/228	0.00% 0/114	3.5% 9/255
Eye disorders Lacrimal disorder	0.44% 1/228	0.00% 0/114	0.00% 0/255
Eye disorders Photopsia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Eye disorders Vitreous floaters	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Diarrhoea	44.7% 102/228	18.4% 21/114	46.7% 119/255
Gastrointestinal disorders Abdominal pain	36.0% 82/228	32.5% 37/114	41.6% 106/255
Gastrointestinal disorders Nausea	35.1% 80/228	24.6% 28/114	44.7% 114/255
Gastrointestinal disorders Vomiting	27.6% 63/228	20.2% 23/114	36.5% 93/255
Gastrointestinal disorders Constipation	23.2% 53/228	19.3% 22/114	29.4% 75/255
Gastrointestinal disorders Dyspepsia	19.7% 45/228	5.3% 6/114	22.0% 56/255
Gastrointestinal disorders Stomatitis	16.2% 37/228	0.88% 1/114	17.3% 44/255
Gastrointestinal disorders Abdominal pain upper	12.3% 28/228	8.8% 10/114	14.5% 37/255
Gastrointestinal disorders Dry mouth	11.4% 26/228	3.5% 4/114	8.6% 22/255
Gastrointestinal disorders Flatulence	10.5% 24/228	4.4% 5/114	10.2% 26/255
Gastrointestinal disorders Abdominal distension	7.9% 18/228	7.9% 9/114	14.9% 38/255
Gastrointestinal disorders Oral pain	7.0% 16/228	0.88% 1/114	11.8% 30/255
Gastrointestinal disorders Glossodynia	5.7% 13/228	0.00% 0/114	7.8% 20/255
Gastrointestinal disorders Gastrooesophageal reflux disease	4.4% 10/228	1.8% 2/114	9.0% 23/255
Gastrointestinal disorders Ascites	3.9% 9/228	5.3% 6/114	3.5% 9/255
Gastrointestinal disorders Abdominal discomfort	3.5% 8/228	0.00% 0/114	3.9% 10/255
Gastrointestinal disorders Rectal haemorrhage	3.5% 8/228	1.8% 2/114	6.3% 16/255
Gastrointestinal disorders Mouth ulceration	3.1% 7/228	0.00% 0/114	2.0% 5/255
Gastrointestinal disorders Dysphagia	2.6% 6/228	0.88% 1/114	4.7% 12/255
Gastrointestinal disorders Gastritis	1.8% 4/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Gingival pain	1.8% 4/228	0.88% 1/114	1.2% 3/255
Gastrointestinal disorders Haemorrhoids	1.8% 4/228	1.8% 2/114	4.7% 12/255
Gastrointestinal disorders Oral discomfort	1.8% 4/228	0.88% 1/114	1.2% 3/255
Gastrointestinal disorders Abdominal pain lower	1.3% 3/228	1.8% 2/114	3.1% 8/255
Gastrointestinal disorders Eructation	1.3% 3/228	1.8% 2/114	2.0% 5/255
Gastrointestinal disorders Lip dry	1.3% 3/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Oesophagitis	1.3% 3/228	0.88% 1/114	2.4% 6/255
Gastrointestinal disorders Oral mucosal discolouration	1.3% 3/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Proctalgia	1.3% 3/228	0.00% 0/114	2.7% 7/255
Gastrointestinal disorders Reflux oesophagitis	1.3% 3/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Retching	1.3% 3/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Salivary hypersecretion	1.3% 3/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Toothache	1.3% 3/228	1.8% 2/114	2.0% 5/255
Gastrointestinal disorders Duodenogastric reflux	0.88% 2/228	0.88% 1/114	0.78% 2/255
Gastrointestinal disorders Gastrointestinal haemorrhage	0.88% 2/228	4.4% 5/114	2.0% 5/255
Gastrointestinal disorders Gingival bleeding	0.88% 2/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Glossitis	0.88% 2/228	0.00% 0/114	2.4% 6/255
Gastrointestinal disorders Haematochezia	0.88% 2/228	1.8% 2/114	1.6% 4/255
Gastrointestinal disorders Intestinal obstruction	0.88% 2/228	0.88% 1/114	0.78% 2/255
Gastrointestinal disorders Lip pain	0.88% 2/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Lip ulceration	0.88% 2/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Melaena	0.88% 2/228	0.88% 1/114	1.6% 4/255
Gastrointestinal disorders Painful defaecation	0.88% 2/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Paraesthesia oral	0.88% 2/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Small intestinal obstruction	0.88% 2/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Stomach discomfort	0.88% 2/228	0.00% 0/114	1.6% 4/255
Gastrointestinal disorders Tongue blistering	0.88% 2/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Aerophagia	0.44% 1/228	0.88% 1/114	0.39% 1/255
Gastrointestinal disorders Anal fissure	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Anal fistula	0.44% 1/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Anal inflammation	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Anorectal discomfort	0.44% 1/228	0.00% 0/114	1.6% 4/255
Gastrointestinal disorders Aphthous stomatitis	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Breath odour	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Chapped lips	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Cheilosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Colitis ulcerative	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Epigastric discomfort	0.44% 1/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Faecal incontinence	0.44% 1/228	0.88% 1/114	0.39% 1/255
Gastrointestinal disorders Gastric haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastric ulcer	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastritis haemorrhagic	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Gastrointestinal obstruction	0.44% 1/228	0.88% 1/114	0.39% 1/255
Gastrointestinal disorders Gastrointestinal pain	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Gingival swelling	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Haematemesis	0.44% 1/228	1.8% 2/114	2.4% 6/255
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Inguinal hernia	0.44% 1/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Intestinal haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Lip swelling	0.44% 1/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Loose tooth	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Mouth haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Odynophagia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Oesophageal haemorrhage	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Oesophageal pain	0.44% 1/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Oesophageal ulcer	0.44% 1/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Periodontal disease	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Periodontitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Proctitis	0.44% 1/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Rectal lesion	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Steatorrhoea	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Tooth discolouration	0.44% 1/228	0.00% 0/114	0.00% 0/255
Gastrointestinal disorders Enterovesical fistula	0.00% 0/228	0.88% 1/114	0.39% 1/255
Gastrointestinal disorders Faeces discoloured	0.00% 0/228	0.88% 1/114	0.00% 0/255
Gastrointestinal disorders Ileus	0.00% 0/228	1.8% 2/114	0.78% 2/255
Gastrointestinal disorders Pancreatitis acute	0.00% 0/228	0.88% 1/114	0.00% 0/255
Gastrointestinal disorders Subileus	0.00% 0/228	0.88% 1/114	0.39% 1/255
Gastrointestinal disorders Varices oesophageal	0.00% 0/228	0.88% 1/114	0.39% 1/255
General disorders Fatigue	45.6% 104/228	35.1% 40/114	61.2% 156/255
General disorders Asthenia	22.4% 51/228	9.6% 11/114	24.3% 62/255
General disorders Mucosal inflammation	17.1% 39/228	0.00% 0/114	19.2% 49/255
General disorders Pyrexia	17.1% 39/228	9.6% 11/114	20.4% 52/255
General disorders Oedema peripheral	13.2% 30/228	13.2% 15/114	28.6% 73/255
General disorders Oedema	7.5% 17/228	0.00% 0/114	5.5% 14/255
General disorders Chest pain	4.4% 10/228	4.4% 5/114	6.7% 17/255
General disorders Chills	3.5% 8/228	1.8% 2/114	3.5% 9/255
General disorders Disease progression	3.5% 8/228	3.5% 4/114	12.9% 33/255
General disorders Pain	3.5% 8/228	1.8% 2/114	5.1% 13/255
General disorders Face oedema	1.3% 3/228	0.00% 0/114	3.5% 9/255
General disorders Localised oedema	1.3% 3/228	0.00% 0/114	1.6% 4/255
General disorders Early satiety	0.88% 2/228	2.6% 3/114	3.5% 9/255
General disorders Influenza like illness	0.88% 2/228	1.8% 2/114	2.0% 5/255
General disorders Malaise	0.88% 2/228	0.00% 0/114	2.4% 6/255
General disorders Chest discomfort	0.44% 1/228	0.00% 0/114	0.78% 2/255
General disorders Discomfort	0.44% 1/228	0.00% 0/114	0.00% 0/255
General disorders Drug interaction	0.44% 1/228	0.00% 0/114	0.00% 0/255
General disorders Facial pain	0.44% 1/228	0.00% 0/114	0.39% 1/255
General disorders Gait disturbance	0.44% 1/228	0.00% 0/114	1.2% 3/255
General disorders General physical health deterioration	0.44% 1/228	2.6% 3/114	2.0% 5/255
General disorders Infusion site reaction	0.44% 1/228	0.00% 0/114	0.00% 0/255
General disorders Multi-organ failure	0.44% 1/228	0.00% 0/114	0.39% 1/255
General disorders Performance status decreased	0.44% 1/228	0.00% 0/114	0.78% 2/255
Hepatobiliary disorders Hepatic pain	1.3% 3/228	0.88% 1/114	2.4% 6/255
Hepatobiliary disorders Hyperbilirubinaemia	1.3% 3/228	0.00% 0/114	1.6% 4/255
Hepatobiliary disorders Jaundice	1.3% 3/228	0.00% 0/114	1.2% 3/255
Hepatobiliary disorders Hepatomegaly	0.88% 2/228	1.8% 2/114	0.78% 2/255
Hepatobiliary disorders Acute hepatic failure	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Bile duct stone	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Cholangitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Cholecystitis acute	0.44% 1/228	0.00% 0/114	0.00% 0/255
Hepatobiliary disorders Cholelithiasis	0.44% 1/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Cholestasis	0.44% 1/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Hepatic failure	0.44% 1/228	0.00% 0/114	0.78% 2/255
Hepatobiliary disorders Hepatic function abnormal	0.44% 1/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Hepatic haemorrhage	0.44% 1/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Portal hypertension	0.44% 1/228	0.00% 0/114	0.00% 0/255
Immune system disorders Hypersensitivity	0.00% 0/228	0.88% 1/114	0.00% 0/255
Infections and infestations Urinary tract infection	4.4% 10/228	2.6% 3/114	8.6% 22/255
Infections and infestations Influenza	3.5% 8/228	1.8% 2/114	5.1% 13/255
Infections and infestations Upper respiratory tract infection	2.6% 6/228	0.88% 1/114	7.1% 18/255
Infections and infestations Cystitis	2.2% 5/228	1.8% 2/114	1.2% 3/255
Infections and infestations Infection	1.8% 4/228	0.00% 0/114	2.4% 6/255
Infections and infestations Nasopharyngitis	1.8% 4/228	2.6% 3/114	4.3% 11/255
Infections and infestations Oral herpes	1.8% 4/228	0.88% 1/114	1.6% 4/255
Infections and infestations Sinusitis	1.8% 4/228	0.88% 1/114	3.1% 8/255
Infections and infestations Bronchitis	1.3% 3/228	0.88% 1/114	0.78% 2/255
Infections and infestations Tooth abscess	1.3% 3/228	0.00% 0/114	0.39% 1/255
Infections and infestations Tooth infection	1.3% 3/228	0.88% 1/114	1.6% 4/255
Infections and infestations Central line infection	0.88% 2/228	0.00% 0/114	0.00% 0/255
Infections and infestations Folliculitis	0.88% 2/228	0.00% 0/114	2.0% 5/255
Infections and infestations Gastroenteritis	0.88% 2/228	0.88% 1/114	4.3% 11/255
Infections and infestations Nail infection	0.88% 2/228	0.00% 0/114	0.39% 1/255
Infections and infestations Abscess limb	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Bacteraemia	0.44% 1/228	0.88% 1/114	0.78% 2/255
Infections and infestations Catheter sepsis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Furuncle	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Gastroenteritis viral	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Gingival abscess	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Gingival infection	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Herpes zoster	0.44% 1/228	0.00% 0/114	2.0% 5/255
Infections and infestations Lobar pneumonia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Localised infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Lower respiratory tract infection	0.44% 1/228	0.88% 1/114	2.4% 6/255
Infections and infestations Mediastinitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Nipple infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Oral candidiasis	0.44% 1/228	2.6% 3/114	1.2% 3/255
Infections and infestations Oral fungal infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Oral infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Pilonidal cyst	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Pneumonia	0.44% 1/228	0.88% 1/114	2.0% 5/255
Infections and infestations Sinusitis bacterial	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Skin infection	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Staphylococcal infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Staphylococcal sepsis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Subcutaneous abscess	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Tinea infection	0.44% 1/228	0.00% 0/114	0.39% 1/255
Infections and infestations Tinea pedis	0.44% 1/228	0.00% 0/114	1.2% 3/255
Infections and infestations Tonsillitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Viral infection	0.44% 1/228	0.88% 1/114	0.00% 0/255
Infections and infestations Viral oesophagitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Wound infection	0.44% 1/228	0.00% 0/114	0.00% 0/255
Infections and infestations Arthritis infective	0.00% 0/228	0.88% 1/114	0.00% 0/255
Infections and infestations Laryngitis	0.00% 0/228	0.88% 1/114	0.78% 2/255
Infections and infestations Postoperative wound infection	0.00% 0/228	0.88% 1/114	0.78% 2/255
Injury, poisoning and procedural complications Contusion	3.9% 9/228	0.88% 1/114	3.5% 9/255
Injury, poisoning and procedural complications Procedural pain	1.3% 3/228	0.88% 1/114	0.78% 2/255
Injury, poisoning and procedural complications Back injury	0.44% 1/228	0.88% 1/114	0.78% 2/255
Injury, poisoning and procedural complications Excoriation	0.44% 1/228	0.00% 0/114	0.78% 2/255
Injury, poisoning and procedural complications Medical device pain	0.44% 1/228	0.00% 0/114	0.00% 0/255
Injury, poisoning and procedural complications Periorbital haematoma	0.44% 1/228	0.00% 0/114	0.00% 0/255
Injury, poisoning and procedural complications Procedural site reaction	0.44% 1/228	0.00% 0/114	0.00% 0/255
Injury, poisoning and procedural complications Radiation oesophagitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Injury, poisoning and procedural complications Spinal compression fracture	0.44% 1/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Spinal fracture	0.44% 1/228	0.00% 0/114	0.00% 0/255
Injury, poisoning and procedural complications Sunburn	0.44% 1/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Wound dehiscence	0.44% 1/228	0.00% 0/114	0.00% 0/255
Injury, poisoning and procedural complications Fall	0.00% 0/228	0.88% 1/114	1.2% 3/255
Injury, poisoning and procedural complications Hepatic haematoma	0.00% 0/228	0.88% 1/114	0.39% 1/255
Injury, poisoning and procedural complications Injury	0.00% 0/228	0.88% 1/114	0.39% 1/255
Injury, poisoning and procedural complications Overdose	0.00% 0/228	0.88% 1/114	0.00% 0/255
Investigations Weight decreased	6.1% 14/228	5.3% 6/114	17.6% 45/255
Investigations Platelet count decreased	3.9% 9/228	0.00% 0/114	5.1% 13/255
Investigations Blood creatinine increased	3.1% 7/228	0.88% 1/114	7.8% 20/255
Investigations Haemoglobin decreased	3.1% 7/228	0.88% 1/114	4.3% 11/255
Investigations Lipase increased	2.6% 6/228	2.6% 3/114	3.1% 8/255
Investigations Blood amylase increased	2.2% 5/228	1.8% 2/114	2.4% 6/255
Investigations Blood bilirubin increased	2.2% 5/228	1.8% 2/114	1.2% 3/255
Investigations White blood cell count decreased	2.2% 5/228	0.00% 0/114	4.7% 12/255
Investigations Blood alkaline phosphatase increased	1.8% 4/228	1.8% 2/114	3.9% 10/255
Investigations Blood creatine phosphokinase increased	1.8% 4/228	0.88% 1/114	0.78% 2/255
Investigations Alanine aminotransferase increased	1.3% 3/228	2.6% 3/114	3.1% 8/255
Investigations Aspartate aminotransferase increased	1.3% 3/228	0.88% 1/114	3.5% 9/255
Investigations Neutrophil count decreased	1.3% 3/228	0.00% 0/114	4.3% 11/255
Investigations Urine output decreased	1.3% 3/228	0.88% 1/114	0.39% 1/255
Investigations Activated partial thromboplastin time prolonged	0.88% 2/228	0.00% 0/114	0.78% 2/255
Investigations International normalised ratio increased	0.88% 2/228	0.00% 0/114	0.78% 2/255
Investigations Prothrombin time prolonged	0.88% 2/228	0.00% 0/114	0.78% 2/255
Investigations Alanine aminotransferase abnormal	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Ammonia increased	0.44% 1/228	0.00% 0/114	1.2% 3/255
Investigations Aspartate aminotransferase abnormal	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Blood alkaline phosphatase abnormal	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Blood bicarbonate decreased	0.44% 1/228	1.8% 2/114	0.78% 2/255
Investigations Blood bilirubin	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Blood creatine phosphokinase	0.44% 1/228	0.88% 1/114	1.2% 3/255
Investigations Blood creatinine	0.44% 1/228	0.88% 1/114	0.39% 1/255
Investigations Blood magnesium decreased	0.44% 1/228	0.00% 0/114	0.78% 2/255
Investigations Blood potassium increased	0.44% 1/228	0.00% 0/114	0.39% 1/255
Investigations Blood pressure increased	0.44% 1/228	0.00% 0/114	0.39% 1/255
Investigations Blood thyroid stimulating hormone increased	0.44% 1/228	0.00% 0/114	0.39% 1/255
Investigations Blood urea increased	0.44% 1/228	0.88% 1/114	1.2% 3/255
Investigations Blood urine present	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Haemoglobin	0.44% 1/228	0.00% 0/114	0.78% 2/255
Investigations Heart rate increased	0.44% 1/228	0.00% 0/114	0.39% 1/255
Investigations Neutrophil count	0.44% 1/228	0.00% 0/114	0.39% 1/255
Investigations Neutrophil count normal	0.44% 1/228	0.88% 1/114	0.00% 0/255
Investigations Oxygen saturation decreased	0.44% 1/228	0.00% 0/114	0.00% 0/255
Investigations Transaminases increased	0.44% 1/228	0.00% 0/114	1.2% 3/255
Investigations Blood glucose increased	0.00% 0/228	0.88% 1/114	1.2% 3/255
Investigations Blood sodium increased	0.00% 0/228	0.88% 1/114	0.00% 0/255
Investigations Breath sounds abnormal	0.00% 0/228	0.88% 1/114	0.39% 1/255
Investigations Cardiac murmur	0.00% 0/228	0.88% 1/114	0.00% 0/255
Investigations Electrocardiogram abnormal	0.00% 0/228	0.88% 1/114	0.00% 0/255
Investigations Heart rate irregular	0.00% 0/228	0.88% 1/114	0.39% 1/255
Investigations Occult blood positive	0.00% 0/228	0.88% 1/114	0.00% 0/255
Investigations Pancreatic enzymes increased	0.00% 0/228	1.8% 2/114	0.39% 1/255
Investigations Platelet count increased	0.00% 0/228	0.88% 1/114	0.78% 2/255
Metabolism and nutrition disorders Anorexia	33.3% 76/228	16.7% 19/114	36.1% 92/255
Metabolism and nutrition disorders Decreased appetite	4.4% 10/228	4.4% 5/114	9.8% 25/255
Metabolism and nutrition disorders Hypokalaemia	4.4% 10/228	0.88% 1/114	5.1% 13/255
Metabolism and nutrition disorders Dehydration	3.9% 9/228	0.00% 0/114	7.5% 19/255
Metabolism and nutrition disorders Hypoalbuminaemia	2.6% 6/228	0.88% 1/114	4.3% 11/255
Metabolism and nutrition disorders Hyperglycaemia	1.8% 4/228	0.00% 0/114	3.9% 10/255
Metabolism and nutrition disorders Hypocalcaemia	1.8% 4/228	0.88% 1/114	1.6% 4/255
Metabolism and nutrition disorders Hypoglycaemia	1.8% 4/228	0.88% 1/114	2.4% 6/255
Metabolism and nutrition disorders Hyponatraemia	1.3% 3/228	1.8% 2/114	1.6% 4/255
Metabolism and nutrition disorders Hypercholesterolaemia	0.88% 2/228	0.00% 0/114	1.6% 4/255
Metabolism and nutrition disorders Hyperuricaemia	0.88% 2/228	0.88% 1/114	1.2% 3/255
Metabolism and nutrition disorders Food intolerance	0.44% 1/228	0.00% 0/114	0.00% 0/255
Metabolism and nutrition disorders Hypercalcaemia	0.44% 1/228	1.8% 2/114	0.78% 2/255
Metabolism and nutrition disorders Hyperkalaemia	0.44% 1/228	0.88% 1/114	0.39% 1/255
Metabolism and nutrition disorders Hyperphosphataemia	0.44% 1/228	0.88% 1/114	0.39% 1/255
Metabolism and nutrition disorders Hypertriglyceridaemia	0.44% 1/228	0.00% 0/114	1.6% 4/255
Metabolism and nutrition disorders Hypophosphataemia	0.44% 1/228	0.00% 0/114	1.6% 4/255
Metabolism and nutrition disorders Hypoproteinaemia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Metabolism and nutrition disorders Metabolic acidosis	0.44% 1/228	0.00% 0/114	0.78% 2/255
Metabolism and nutrition disorders Acidosis	0.00% 0/228	0.88% 1/114	0.00% 0/255
Metabolism and nutrition disorders Appetite disorder	0.00% 0/228	0.88% 1/114	0.00% 0/255
Metabolism and nutrition disorders Gout	0.00% 0/228	0.88% 1/114	0.78% 2/255
Metabolism and nutrition disorders Increased appetite	0.00% 0/228	1.8% 2/114	0.39% 1/255
Metabolism and nutrition disorders Malnutrition	0.00% 0/228	0.88% 1/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Back pain	13.6% 31/228	12.3% 14/114	20.0% 51/255
Musculoskeletal and connective tissue disorders Pain in extremity	12.3% 28/228	3.5% 4/114	18.0% 46/255
Musculoskeletal and connective tissue disorders Arthralgia	10.1% 23/228	7.0% 8/114	20.0% 51/255
Musculoskeletal and connective tissue disorders Muscle spasms	6.6% 15/228	4.4% 5/114	10.6% 27/255
Musculoskeletal and connective tissue disorders Myalgia	6.6% 15/228	3.5% 4/114	9.8% 25/255
Musculoskeletal and connective tissue disorders Flank pain	3.9% 9/228	0.00% 0/114	3.9% 10/255
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.9% 9/228	4.4% 5/114	11.0% 28/255
Musculoskeletal and connective tissue disorders Muscular weakness	3.1% 7/228	0.88% 1/114	4.3% 11/255
Musculoskeletal and connective tissue disorders Neck pain	2.6% 6/228	1.8% 2/114	4.7% 12/255
Musculoskeletal and connective tissue disorders Bone pain	2.2% 5/228	1.8% 2/114	3.5% 9/255
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.8% 4/228	0.00% 0/114	1.2% 3/255
Musculoskeletal and connective tissue disorders Joint stiffness	0.88% 2/228	0.00% 0/114	1.6% 4/255
Musculoskeletal and connective tissue disorders Limb discomfort	0.88% 2/228	0.00% 0/114	1.6% 4/255
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.88% 2/228	2.6% 3/114	2.0% 5/255
Musculoskeletal and connective tissue disorders Pain in jaw	0.88% 2/228	0.00% 0/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Exostosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Fistula	0.44% 1/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Groin pain	0.44% 1/228	2.6% 3/114	2.0% 5/255
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.44% 1/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Joint effusion	0.44% 1/228	0.00% 0/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.44% 1/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Muscle tightness	0.44% 1/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Muscle twitching	0.44% 1/228	0.00% 0/114	0.78% 2/255
Musculoskeletal and connective tissue disorders Osteoporosis	0.44% 1/228	0.00% 0/114	0.78% 2/255
Musculoskeletal and connective tissue disorders Tendonitis	0.44% 1/228	0.88% 1/114	0.78% 2/255
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/228	0.88% 1/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/228	0.88% 1/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/228	0.88% 1/114	0.00% 0/255
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/228	0.88% 1/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.3% 3/228	0.00% 0/114	1.2% 3/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.44% 1/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.44% 1/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemorrhagic tumour necrosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Chromaturia	5.3% 12/228	1.8% 2/114	2.4% 6/255
Renal and urinary disorders Dysuria	4.4% 10/228	0.88% 1/114	4.7% 12/255
Renal and urinary disorders Haematuria	2.6% 6/228	1.8% 2/114	3.1% 8/255
Renal and urinary disorders Urinary retention	1.8% 4/228	0.00% 0/114	1.2% 3/255
Renal and urinary disorders Hydronephrosis	1.3% 3/228	2.6% 3/114	2.4% 6/255
Renal and urinary disorders Pollakiuria	1.3% 3/228	3.5% 4/114	4.3% 11/255
Renal and urinary disorders Polyuria	0.88% 2/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Proteinuria	0.88% 2/228	0.88% 1/114	1.2% 3/255
Renal and urinary disorders Bladder pain	0.44% 1/228	0.00% 0/114	0.78% 2/255
Renal and urinary disorders Choluria	0.44% 1/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Nephrotic syndrome	0.44% 1/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Nocturia	0.44% 1/228	0.88% 1/114	0.78% 2/255
Renal and urinary disorders Oliguria	0.44% 1/228	0.00% 0/114	1.2% 3/255
Renal and urinary disorders Renal colic	0.44% 1/228	0.00% 0/114	0.00% 0/255
Renal and urinary disorders Renal failure	0.44% 1/228	0.00% 0/114	0.78% 2/255
Renal and urinary disorders Renal failure acute	0.44% 1/228	0.88% 1/114	0.78% 2/255
Renal and urinary disorders Urine odour abnormal	0.44% 1/228	0.00% 0/114	0.78% 2/255
Renal and urinary disorders Bladder spasm	0.00% 0/228	0.88% 1/114	0.78% 2/255
Renal and urinary disorders Hydroureter	0.00% 0/228	0.88% 1/114	0.78% 2/255
Renal and urinary disorders Micturition urgency	0.00% 0/228	0.88% 1/114	1.2% 3/255
Renal and urinary disorders Ureteric obstruction	0.00% 0/228	0.88% 1/114	0.00% 0/255
Renal and urinary disorders Urethral stenosis	0.00% 0/228	0.88% 1/114	0.78% 2/255
Renal and urinary disorders Urinary incontinence	0.00% 0/228	0.88% 1/114	1.2% 3/255
Reproductive system and breast disorders Gynaecomastia	1.8% 4/228	0.00% 0/114	0.78% 2/255
Reproductive system and breast disorders Pelvic pain	1.8% 4/228	2.6% 3/114	4.3% 11/255
Reproductive system and breast disorders Oedema genital	0.88% 2/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Atrophic vulvovaginitis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Genital discomfort	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Genital pain	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Genital rash	0.00% 0/228	0.00% 0/114	0.78% 2/255
Reproductive system and breast disorders Menstruation delayed	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Metrorrhagia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Nipple pain	0.44% 1/228	0.88% 1/114	0.00% 0/255
Reproductive system and breast disorders Pelvic discomfort	0.44% 1/228	0.88% 1/114	0.78% 2/255
Reproductive system and breast disorders Vaginal erythema	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Vaginal haemorrhage	0.44% 1/228	0.00% 0/114	1.6% 4/255
Reproductive system and breast disorders Vaginal pain	0.44% 1/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Vulval ulceration	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Vulvovaginal burning sensation	0.44% 1/228	0.00% 0/114	0.00% 0/255
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/228	0.88% 1/114	0.39% 1/255
Reproductive system and breast disorders Breast mass	0.00% 0/228	0.88% 1/114	0.78% 2/255
Reproductive system and breast disorders Breast pain	0.00% 0/228	0.88% 1/114	0.00% 0/255
Reproductive system and breast disorders Perineal pain	0.00% 0/228	0.88% 1/114	0.39% 1/255
Reproductive system and breast disorders Prostatitis	0.00% 0/228	0.88% 1/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.0% 25/228	14.0% 16/114	22.0% 56/255
Respiratory, thoracic and mediastinal disorders Epistaxis	9.6% 22/228	0.00% 0/114	10.6% 27/255
Respiratory, thoracic and mediastinal disorders Cough	8.3% 19/228	12.3% 14/114	16.9% 43/255
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.9% 9/228	2.6% 3/114	6.7% 17/255
Respiratory, thoracic and mediastinal disorders Hiccups	1.8% 4/228	0.88% 1/114	2.4% 6/255
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 4/228	0.88% 1/114	2.7% 7/255
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 4/228	2.6% 3/114	2.0% 5/255
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.8% 4/228	0.00% 0/114	2.7% 7/255
Respiratory, thoracic and mediastinal disorders Dysphonia	1.3% 3/228	0.88% 1/114	1.2% 3/255
Respiratory, thoracic and mediastinal disorders Dry throat	0.88% 2/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.88% 2/228	1.8% 2/114	3.5% 9/255
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.88% 2/228	0.00% 0/114	2.0% 5/255
Respiratory, thoracic and mediastinal disorders Productive cough	0.88% 2/228	0.88% 1/114	1.6% 4/255
Respiratory, thoracic and mediastinal disorders Atelectasis	0.44% 1/228	0.00% 0/114	1.2% 3/255
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.44% 1/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Hypoxia	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.44% 1/228	0.00% 0/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.44% 1/228	0.00% 0/114	2.4% 6/255
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.44% 1/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.44% 1/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Painful respiration	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal discomfort	0.44% 1/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.44% 1/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Rales	0.44% 1/228	0.88% 1/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.44% 1/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Throat irritation	0.44% 1/228	0.00% 0/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/228	0.88% 1/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/228	0.88% 1/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/228	0.88% 1/114	0.00% 0/255
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/228	0.88% 1/114	1.6% 4/255
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/228	0.88% 1/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/228	0.88% 1/114	0.00% 0/255
Skin and subcutaneous tissue disorders Skin discolouration	28.1% 64/228	6.1% 7/114	30.2% 77/255
Skin and subcutaneous tissue disorders Rash	17.5% 40/228	6.1% 7/114	18.8% 48/255
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	11.0% 25/228	0.88% 1/114	22.0% 56/255
Skin and subcutaneous tissue disorders Hair colour changes	8.3% 19/228	1.8% 2/114	19.6% 50/255
Skin and subcutaneous tissue disorders Dry skin	7.5% 17/228	2.6% 3/114	12.9% 33/255
Skin and subcutaneous tissue disorders Alopecia	6.1% 14/228	0.88% 1/114	8.6% 22/255
Skin and subcutaneous tissue disorders Skin reaction	5.7% 13/228	0.00% 0/114	8.6% 22/255
Skin and subcutaneous tissue disorders Pruritus	4.8% 11/228	3.5% 4/114	8.2% 21/255
Skin and subcutaneous tissue disorders Erythema	4.4% 10/228	2.6% 3/114	7.1% 18/255
Skin and subcutaneous tissue disorders Eczema	3.5% 8/228	1.8% 2/114	5.5% 14/255
Skin and subcutaneous tissue disorders Night sweats	3.5% 8/228	2.6% 3/114	3.9% 10/255
Skin and subcutaneous tissue disorders Periorbital oedema	3.5% 8/228	0.00% 0/114	5.1% 13/255
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.5% 8/228	0.00% 0/114	3.1% 8/255
Skin and subcutaneous tissue disorders Dermatitis	2.6% 6/228	0.00% 0/114	2.4% 6/255
Skin and subcutaneous tissue disorders Hyperhidrosis	2.2% 5/228	2.6% 3/114	3.1% 8/255
Skin and subcutaneous tissue disorders Skin exfoliation	2.2% 5/228	0.00% 0/114	3.1% 8/255
Skin and subcutaneous tissue disorders Blister	1.8% 4/228	0.00% 0/114	3.5% 9/255
Skin and subcutaneous tissue disorders Ecchymosis	1.8% 4/228	0.00% 0/114	2.4% 6/255
Skin and subcutaneous tissue disorders Hyperkeratosis	1.8% 4/228	0.00% 0/114	3.9% 10/255
Skin and subcutaneous tissue disorders Petechiae	1.8% 4/228	0.00% 0/114	2.0% 5/255
Skin and subcutaneous tissue disorders Skin fissures	1.8% 4/228	0.00% 0/114	3.1% 8/255
Skin and subcutaneous tissue disorders Acne	1.3% 3/228	0.00% 0/114	1.6% 4/255
Skin and subcutaneous tissue disorders Nail disorder	1.3% 3/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Skin lesion	1.3% 3/228	0.88% 1/114	3.5% 9/255
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.88% 2/228	0.88% 1/114	0.00% 0/255
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.88% 2/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Increased tendency to bruise	0.88% 2/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Nail discolouration	0.88% 2/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Pigmentation disorder	0.88% 2/228	0.00% 0/114	1.6% 4/255
Skin and subcutaneous tissue disorders Rash erythematous	0.88% 2/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Rash macular	0.88% 2/228	0.88% 1/114	0.78% 2/255
Skin and subcutaneous tissue disorders Urticaria	0.88% 2/228	0.88% 1/114	0.00% 0/255
Skin and subcutaneous tissue disorders Acrodermatitis	0.44% 1/228	0.00% 0/114	2.0% 5/255
Skin and subcutaneous tissue disorders Cold sweat	0.44% 1/228	0.88% 1/114	0.00% 0/255
Skin and subcutaneous tissue disorders Dermal cyst	0.44% 1/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Diabetic ulcer	0.44% 1/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Erythema nodosum	0.44% 1/228	0.00% 0/114	0.00% 0/255
Skin and subcutaneous tissue disorders Madarosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Skin and subcutaneous tissue disorders Pain of skin	0.44% 1/228	0.00% 0/114	1.2% 3/255
Skin and subcutaneous tissue disorders Palmar erythema	0.44% 1/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Plantar erythema	0.44% 1/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Rash generalised	0.44% 1/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Skin atrophy	0.44% 1/228	0.00% 0/114	0.00% 0/255
Skin and subcutaneous tissue disorders Skin depigmentation	0.44% 1/228	0.00% 0/114	0.00% 0/255
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.44% 1/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Skin toxicity	0.44% 1/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Skin ulcer	0.44% 1/228	0.00% 0/114	1.2% 3/255
Skin and subcutaneous tissue disorders Swelling face	0.44% 1/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/228	0.88% 1/114	0.00% 0/255
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/228	0.88% 1/114	0.39% 1/255
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/228	0.88% 1/114	0.39% 1/255
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/228	0.88% 1/114	1.2% 3/255
Skin and subcutaneous tissue disorders Subcutaneous nodule	0.00% 0/228	0.88% 1/114	0.78% 2/255
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/228	0.88% 1/114	0.78% 2/255
Surgical and medical procedures Skin lesion excision	0.44% 1/228	0.00% 0/114	0.00% 0/255
Surgical and medical procedures Pneumatic compression therapy	0.00% 0/228	0.88% 1/114	0.39% 1/255
Vascular disorders Hypertension	17.5% 40/228	7.9% 9/114	27.8% 71/255
Vascular disorders Hot flush	3.9% 9/228	2.6% 3/114	2.7% 7/255
Vascular disorders Deep vein thrombosis	1.8% 4/228	0.00% 0/114	2.0% 5/255
Vascular disorders Hypotension	1.3% 3/228	0.88% 1/114	2.4% 6/255
Vascular disorders Pallor	1.3% 3/228	0.00% 0/114	0.39% 1/255
Vascular disorders Haemorrhage	0.88% 2/228	0.88% 1/114	0.78% 2/255
Vascular disorders Hypertensive crisis	0.88% 2/228	0.00% 0/114	1.2% 3/255
Vascular disorders Vasculitis	0.88% 2/228	0.00% 0/114	0.00% 0/255
Vascular disorders Venous thrombosis limb	0.88% 2/228	0.00% 0/114	0.00% 0/255
Vascular disorders Lymphoedema	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Orthostatic hypotension	0.44% 1/228	0.00% 0/114	0.39% 1/255
Vascular disorders Systolic hypertension	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Thrombosis	0.44% 1/228	0.00% 0/114	0.00% 0/255
Vascular disorders Vasodilatation	0.44% 1/228	0.00% 0/114	0.39% 1/255
Vascular disorders Circulatory collapse	0.00% 0/228	0.88% 1/114	0.00% 0/255
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders haemolytic anaemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Blood and lymphatic system disorders Leukocytosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Cardiac failure congestive	0.00% 0/228	0.00% 0/114	0.78% 2/255
Cardiac disorders Cardio-respiratory arrest	0.00% 0/228	0.00% 0/114	0.78% 2/255
Cardiac disorders Sinus bradycardia	0.00% 0/228	0.00% 0/114	0.78% 2/255
Cardiac disorders Ventricular hypokinesia	0.00% 0/228	0.00% 0/114	0.78% 2/255
Cardiac disorders Left ventricular hypertrophy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Myocardial infarction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Myocardial ischaemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Splinter haemorhages	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Supraventricular tachycardia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Cardiac disorders Ventricular dysfunction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/228	0.00% 0/114	0.39% 1/255
Congenital, familial and genetic disorders Epidermolysis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Congenital, familial and genetic disorders Hydrocele	0.00% 0/228	0.00% 0/114	0.39% 1/255
Ear and labyrinth disorders Dysacusis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Ear and labyrinth disorders Hearing impaired	0.00% 0/228	0.00% 0/114	0.39% 1/255
Endocrine disorders Hyperthyroidism	0.00% 0/228	0.00% 0/114	1.2% 3/255
Endocrine disorders Thyroid disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Eye pain	0.00% 0/228	0.00% 0/114	1.2% 3/255
Eye disorders Eye pruritus	0.00% 0/228	0.00% 0/114	1.2% 3/255
Eye disorders Dry eye	0.00% 0/228	0.00% 0/114	0.78% 2/255
Eye disorders Glaucoma	0.00% 0/228	0.00% 0/114	0.78% 2/255
Eye disorders Macular degeneration	0.00% 0/228	0.00% 0/114	0.78% 2/255
Eye disorders Orbital oedema	0.00% 0/228	0.00% 0/114	0.78% 2/255
Eye disorders Asthenopia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Blepharitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Eye discharge	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Eye haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Eye irritation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Eye swelling	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Ocular hyperaemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Punctate keratitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Scleral haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Eye disorders Visual acuity reduced	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Abdominal tenderness	0.00% 0/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Hiatus hernia	0.00% 0/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Anal haemorrhage	0.00% 0/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Gingivitis	0.00% 0/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Rectal tenesmus	0.00% 0/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/228	0.00% 0/114	0.78% 2/255
Gastrointestinal disorders Abdominal hernia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Abdominal mass	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Abdominal rigidity	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Defaecation urgency	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Dental caries	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Diverticulum	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Duodenal fistula	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Duodenal ulcer	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Enamel anomaly	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Salivary gland enlargement	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Swollen tongue	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Tongue disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Tongue spasm	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Tongue ulceration	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Tooth erosion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Umbilical hernia	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Feeling hot	0.00% 0/228	0.00% 0/114	0.78% 2/255
General disorders Ill-defined disorder	0.00% 0/228	0.00% 0/114	0.78% 2/255
General disorders Impaired healing	0.00% 0/228	0.00% 0/114	0.78% 2/255
General disorders Catheter related complication	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Catheter site discharge	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Catheter site excoriation	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Catheter site pain	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Cyst	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Effusion	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Feeling cold	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Hernia pain	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Infusion site extravasation	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Irritability	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Mucosal dryness	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Necrosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Peripheral coldness	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Pneumatosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Thirst	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Ulcer haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
General disorders Xerosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Hepatotoxicity	0.00% 0/228	0.00% 0/114	0.78% 2/255
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/228	0.00% 0/114	0.78% 2/255
Hepatobiliary disorders Cholecystitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Hepatobiliary disorders Foetor hepaticus	0.00% 0/228	0.00% 0/114	0.39% 1/255
Immune system disorders Seasonal allergy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Respiratory tract infection	0.00% 0/228	0.00% 0/114	2.0% 5/255
Infections and infestations Rhinitis	0.00% 0/228	0.00% 0/114	2.4% 6/255
Infections and infestations Cellulitis	0.00% 0/228	0.00% 0/114	1.2% 3/255
Infections and infestations Ear infection	0.00% 0/228	0.00% 0/114	1.2% 3/255
Infections and infestations Pharyngitis	0.00% 0/228	0.00% 0/114	1.2% 3/255
Infections and infestations Sepsis	0.00% 0/228	0.00% 0/114	1.2% 3/255
Infections and infestations Abdominal abscess	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Anal infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Bacterial infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Campylobacter infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Diverticulitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Empyema	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Fungal infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Gastrointestinal infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Genital herpes	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Herpes simplex	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Infected skin ulcer	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Liver abscess	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Lung infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Necrotising ulcerative gingivostomatitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Oesophageal candidiasis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Orchitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Osteomyelitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Otitis media	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Perirectal abscess	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Proctitis monilial	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Pyelonephritis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Urinary tract infection fungal	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Urosepsis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Infections and infestations Viral upper respiratory tract infection	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Skin laceration	0.00% 0/228	0.00% 0/114	1.6% 4/255
Injury, poisoning and procedural complications Thermal burn	0.00% 0/228	0.00% 0/114	0.78% 2/255
Injury, poisoning and procedural complications Wound	0.00% 0/228	0.00% 0/114	0.78% 2/255
Injury, poisoning and procedural complications Anal injury	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Device malfunction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Feeding tube complication	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Joint sprain	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Limb injury	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Medical device complication	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Medical device site reaction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Medication error	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Muscle strain	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Neck injury	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Post gastric surgery syndrome	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Post procedural diarrhoea	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Postoperative constipation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/228	0.00% 0/114	0.39% 1/255
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Weight increased	0.00% 0/228	0.00% 0/114	2.4% 6/255
Investigations Blood lactate dehydrogenase increased	0.00% 0/228	0.00% 0/114	2.0% 5/255
Investigations Blood potassium decreased	0.00% 0/228	0.00% 0/114	1.6% 4/255
Investigations Blood uric acid increased	0.00% 0/228	0.00% 0/114	1.6% 4/255
Investigations Blood albumin decreased	0.00% 0/228	0.00% 0/114	1.2% 3/255
Investigations Liver function test abnormal	0.00% 0/228	0.00% 0/114	0.78% 2/255
Investigations Platelet count	0.00% 0/228	0.00% 0/114	0.78% 2/255
Investigations Bacterial culture positive	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood alkaline phosphatase	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood calcium decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood glucose decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood phosphorus decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations C-reactive protein increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations ECG signs of myocardial ischaemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Electrocardiogram ST segment depression	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Gamma-glutamyltransferase increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Hepatic enzyme increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Lymph node palpable	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Lymphocyte count decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Mean cell volume increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Multiple gated acquisition scan abnormal	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Venous pressure jugular increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Vitamin B12 decreased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations White blood cell count	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations White blood cell count increased	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/228	0.00% 0/114	2.0% 5/255
Metabolism and nutrition disorders Cachexia	0.00% 0/228	0.00% 0/114	0.78% 2/255
Metabolism and nutrition disorders Cow's milk intolerance	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Fluid retention	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Iron deficiency	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/228	0.00% 0/114	0.39% 1/255
Metabolism and nutrition disorders Polydipsia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/228	0.00% 0/114	1.2% 3/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal neoplasm	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma benign	0.00% 0/228	0.00% 0/114	0.39% 1/255
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour perforation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Hepatic encephalopathy	0.00% 0/228	0.00% 0/114	2.0% 5/255
Nervous system disorders Dysarthria	0.00% 0/228	0.00% 0/114	0.78% 2/255
Nervous system disorders Loss of consciousness	0.00% 0/228	0.00% 0/114	0.78% 2/255
Nervous system disorders Aphonia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Asterixis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Carotid artery disease	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Cerebral haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Cervical root pain	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Convulsion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Dysaesthesia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Guillain-barre syndrome	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Hemiparesis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Hypogeusia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Intention tremor	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Intracranial venous sinus thrombosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Lacunar infarction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Migraine with aura	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Movement disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Nervous system disorders Petit mal epilepsy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Mood altered	0.00% 0/228	0.00% 0/114	0.78% 2/255
Psychiatric disorders Abnormal dreams	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Apathy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Completed suicide	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Dysphemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Emotional disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Hallucination	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Psychomotor retardation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Psychiatric disorders Psychotic disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Renal impairment	0.00% 0/228	0.00% 0/114	1.2% 3/255
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Obstructive uropathy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Renal cyst	0.00% 0/228	0.00% 0/114	0.39% 1/255
Renal and urinary disorders Residual urine	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Scrotal oedema	0.00% 0/228	0.00% 0/114	1.2% 3/255
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/228	0.00% 0/114	0.78% 2/255
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/228	0.00% 0/114	0.78% 2/255
Reproductive system and breast disorders Genital lesion	0.00% 0/228	0.00% 0/114	0.78% 2/255
Reproductive system and breast disorders Balanoposthitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Breast swelling	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Dyspareunia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Genital erythema	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Menstruation irregular	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Penile oedema	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Perineal fistula	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Pruritus genital	0.00% 0/228	0.00% 0/114	0.39% 1/255
Reproductive system and breast disorders Uterine polyp	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/228	0.00% 0/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/228	0.00% 0/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/228	0.00% 0/114	0.78% 2/255
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/228	0.00% 0/114	0.39% 1/255
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Purpura	0.00% 0/228	0.00% 0/114	2.0% 5/255
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/228	0.00% 0/114	1.6% 4/255
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/228	0.00% 0/114	1.6% 4/255
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/228	0.00% 0/114	1.2% 3/255
Skin and subcutaneous tissue disorders Yellow skin	0.00% 0/228	0.00% 0/114	1.2% 3/255
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/228	0.00% 0/114	0.78% 2/255
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Skin chapped	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/228	0.00% 0/114	0.39% 1/255
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Cyst drainage	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Debridement	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Hepatic embolisation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Mediastinal operation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Packed red blood cell transfusion	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Sinus operation	0.00% 0/228	0.00% 0/114	0.39% 1/255
Surgical and medical procedures Stent placement	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Flushing	0.00% 0/228	0.00% 0/114	1.6% 4/255
Vascular disorders Thrombophlebitis	0.00% 0/228	0.00% 0/114	0.78% 2/255
Vascular disorders Embolism	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Essential hypertension	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Jugular vein thrombosis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Peripheral ischaemia	0.00% 0/228	0.00% 0/114	0.39% 1/255
Vascular disorders Phlebitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Gastrointestinal disorders Cheilitis	0.00% 0/228	0.00% 0/114	1.2% 3/255
Gastrointestinal disorders Colitis	0.00% 0/228	0.00% 0/114	0.39% 1/255
Investigations Blood sodium decreased	0.00% 0/228	0.00% 0/114	0.78% 2/255

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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