Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00471146

First received: May 7, 2007

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Results First Received: February 25, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Carcinoma, Pancreatic Ductal
Interventions:	Drug: AG-013736 Drug: Gemcitabine Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Axitinib + Gemcitabine	Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine	Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Participant Flow: Overall Study

	Axitinib + Gemcitabine	Placebo + Gemcitabine
STARTED	314	316
Treated	305	308
COMPLETED	142	142
NOT COMPLETED	172	174
Adverse Event	32	33
Withdrawal by Subject	14	11
Death	11	12
Lost to Follow-up	4	2
Protocol Violation	2	2
Objective progression or relapse	84	87
Global deterioration of health status	12	14
Randomized but not treated	9	8
Unspecified	4	5

Baseline Characteristics

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Reporting Groups

	Description
Axitinib + Gemcitabine	Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine	Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Total	Total of all reporting groups

Baseline Measures

	Axitinib + Gemcitabine	Placebo + Gemcitabine	Total
Number of Participants [units: participants]	314	316	630
Age, Customized [units: Participants]
Less than 65 years	203	179	382
Greater than or equal to 65 years	111	137	248
Gender [units: Participants]
Female	123	128	251
Male	191	188	379

Outcome Measures

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1. Primary:

Overall Survival (OS) [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]

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2. Secondary:

Progression Free Survival (PFS) [ Time Frame: Baseline until disease progression or at least 1 year after the randomization of last participant ]

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3. Secondary:

Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, every 8 weeks until tumor progression or death ]

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4. Secondary:

Duration of Response (DR) [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]

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5. Secondary:

Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Show Outcome Measure 8

9. Secondary:

Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Show Outcome Measure 9

10. Secondary:

Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) [ Time Frame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Axitinib + Gemcitabine	Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine	Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Other Adverse Events

	Axitinib + Gemcitabine	Placebo + Gemcitabine
Total, other (not including serious) adverse events
# participants affected / at risk	276/304	276/309
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	25/304 (8.22%)	51/309 (16.50%)
Disseminated intravascular coagulation ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Eosinopenia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Erythroblastosis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Erythropenia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Granulocytopenia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Haemoglobinaemia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Iron deficiency anaemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Leukocytosis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Leukopenia ^{* 1}
# participants affected / at risk	23/304 (7.57%)	13/309 (4.21%)
Lymphadenopathy ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lymphocytosis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lymphopenia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	7/309 (2.27%)
Neutropenia ^{* 1}
# participants affected / at risk	73/304 (24.01%)	53/309 (17.15%)
Neutrophilia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Thrombocytopenia ^{* 1}
# participants affected / at risk	48/304 (15.79%)	34/309 (11.00%)
Thrombocytosis ^{* 1}
# participants affected / at risk	4/304 (1.32%)	3/309 (0.97%)
Cardiac disorders
Atrial fibrillation ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Atrial flutter ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Bradycardia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Bundle branch block right ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Cardiovascular disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Cyanosis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Diastolic dysfunction ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Mitral valve incompetence ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Nodal rhythm ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Palpitations ^{* 1}
# participants affected / at risk	4/304 (1.32%)	2/309 (0.65%)
Pericardial effusion ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Splinter haemorrhages ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Supraventricular extrasystoles ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Tachycardia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	5/309 (1.62%)
Ventricular tachycardia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Congenital, familial and genetic disorders
Congenital foot malformation ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Ear and labyrinth disorders
Auricular perichondritis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Cerumen impaction ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Deafness ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Ear discomfort ^{* 1}
# participants affected / at risk	5/304 (1.64%)	1/309 (0.32%)
Ear pain ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Hypoacusis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Tinnitus ^{* 1}
# participants affected / at risk	5/304 (1.64%)	0/309 (0.00%)
Vertigo ^{* 1}
# participants affected / at risk	4/304 (1.32%)	5/309 (1.62%)
Endocrine disorders
Hyperthyroidism ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Hypoparathyroidism ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hypothyroidism ^{* 1}
# participants affected / at risk	15/304 (4.93%)	4/309 (1.29%)
Thyroiditis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Eye disorders
Asthenopia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Conjunctivitis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Diplopia ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Dry eye ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Eye pruritus ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Eyelid oedema ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lacrimation increased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	2/309 (0.65%)
Ocular discomfort ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Ocular hyperaemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Scotoma ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Vision blurred ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Visual acuity reduced ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Gastrointestinal disorders
Abdominal discomfort ^{* 1}
# participants affected / at risk	3/304 (0.99%)	5/309 (1.62%)
Abdominal distension ^{* 1}
# participants affected / at risk	12/304 (3.95%)	12/309 (3.88%)
Abdominal hernia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Abdominal mass ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Abdominal pain ^{* 1}
# participants affected / at risk	54/304 (17.76%)	52/309 (16.83%)
Abdominal pain lower ^{* 1}
# participants affected / at risk	2/304 (0.66%)	5/309 (1.62%)
Abdominal pain upper ^{* 1}
# participants affected / at risk	24/304 (7.89%)	24/309 (7.77%)
Abdominal tenderness ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Anal haemorrhage ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Aphthous stomatitis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Ascites ^{* 1}
# participants affected / at risk	5/304 (1.64%)	9/309 (2.91%)
Cheilitis ^{* 1}
# participants affected / at risk	4/304 (1.32%)	1/309 (0.32%)
Colitis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Constipation ^{* 1}
# participants affected / at risk	88/304 (28.95%)	91/309 (29.45%)
Dental caries ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Diarrhoea ^{* 1}
# participants affected / at risk	96/304 (31.58%)	64/309 (20.71%)
Dry mouth ^{* 1}
# participants affected / at risk	14/304 (4.61%)	14/309 (4.53%)
Duodenal obstruction ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Duodenal ulcer ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Duodenogastric reflux ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Dyspepsia ^{* 1}
# participants affected / at risk	14/304 (4.61%)	22/309 (7.12%)
Dysphagia ^{* 1}
# participants affected / at risk	7/304 (2.30%)	1/309 (0.32%)
Enteritis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Eructation ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Faeces discoloured ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Faeces pale ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Flatulence ^{* 1}
# participants affected / at risk	8/304 (2.63%)	9/309 (2.91%)
Frequent bowel movements ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Gastritis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Gastritis erosive ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Gastrointestinal disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Gastrointestinal obstruction ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Gastrooesophageal reflux disease ^{* 1}
# participants affected / at risk	6/304 (1.97%)	4/309 (1.29%)
Gingival bleeding ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Gingival pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Gingival ulceration ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Gingivitis ^{* 1}
# participants affected / at risk	6/304 (1.97%)	1/309 (0.32%)
Glossitis ^{* 1}
# participants affected / at risk	7/304 (2.30%)	0/309 (0.00%)
Glossodynia ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Haematemesis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Haematochezia ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Haemorrhoids ^{* 1}
# participants affected / at risk	4/304 (1.32%)	5/309 (1.62%)
Hiatus hernia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Ileus ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Intestinal obstruction ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Lip dry ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Mouth ulceration ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Nausea ^{* 1}
# participants affected / at risk	138/304 (45.39%)	112/309 (36.25%)
Odynophagia ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Oesophageal pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Oesophagitis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Oral discomfort ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Oral disorder ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Oral dysaesthesia ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Oral pain ^{* 1}
# participants affected / at risk	4/304 (1.32%)	0/309 (0.00%)
Pancreatic insufficiency ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pancreatitis acute ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Periodontitis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Pneumoperitoneum ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Proctalgia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Rectal haemorrhage ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Reflux gastritis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Reflux oesophagitis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Regurgitation ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Retching ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Salivary hypersecretion ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Steatorrhoea ^{* 1}
# participants affected / at risk	2/304 (0.66%)	2/309 (0.65%)
Stomatitis ^{* 1}
# participants affected / at risk	52/304 (17.11%)	12/309 (3.88%)
Thrombosis mesenteric vessel ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Toothache ^{* 1}
# participants affected / at risk	3/304 (0.99%)	2/309 (0.65%)
Vomiting ^{* 1}
# participants affected / at risk	91/304 (29.93%)	95/309 (30.74%)
Mass ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
General disorders
Adhesion ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Asthenia ^{* 1}
# participants affected / at risk	38/304 (12.50%)	38/309 (12.30%)
Catheter site erythema ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Catheter site haemorrhage ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Catheter site pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Catheter site pruritus ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Chest discomfort ^{* 1}
# participants affected / at risk	2/304 (0.66%)	2/309 (0.65%)
Chest pain ^{* 1}
# participants affected / at risk	10/304 (3.29%)	6/309 (1.94%)
Chills ^{* 1}
# participants affected / at risk	13/304 (4.28%)	11/309 (3.56%)
Device occlusion ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Early satiety ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Face oedema ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Fatigue ^{* 1}
# participants affected / at risk	125/304 (41.12%)	113/309 (36.57%)
Feeling cold ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Feeling hot ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
General physical health deterioration ^{* 1}
# participants affected / at risk	6/304 (1.97%)	2/309 (0.65%)
Generalised oedema ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hernia pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hyperthermia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Influenza like illness ^{* 1}
# participants affected / at risk	9/304 (2.96%)	9/309 (2.91%)
Injection site extravasation ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Injection site reaction ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Malaise ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Mucosal dryness ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Mucosal inflammation ^{* 1}
# participants affected / at risk	34/304 (11.18%)	13/309 (4.21%)
Oedema ^{* 1}
# participants affected / at risk	6/304 (1.97%)	5/309 (1.62%)
Oedema peripheral ^{* 1}
# participants affected / at risk	22/304 (7.24%)	46/309 (14.89%)
Pain ^{* 1}
# participants affected / at risk	16/304 (5.26%)	7/309 (2.27%)
Performance status decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Pyrexia ^{* 1}
# participants affected / at risk	38/304 (12.50%)	44/309 (14.24%)
Thirst ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Thrombosis in device ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Ulcer ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hepatobiliary disorders
Bile duct obstruction ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Cholangitis ^{* 1}
# participants affected / at risk	4/304 (1.32%)	4/309 (1.29%)
Cholestasis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Cytolytic hepatitis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hepatic function abnormal ^{* 1}
# participants affected / at risk	4/304 (1.32%)	2/309 (0.65%)
Hepatic pain ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hepatomegaly ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Hepatorenal syndrome ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hepatotoxicity ^{* 1}
# participants affected / at risk	6/304 (1.97%)	1/309 (0.32%)
Hyperbilirubinaemia ^{* 1}
# participants affected / at risk	6/304 (1.97%)	9/309 (2.91%)
Jaundice ^{* 1}
# participants affected / at risk	3/304 (0.99%)	1/309 (0.32%)
Liver disorder ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Liver tenderness ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Portal vein thrombosis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Immune system disorders
Contrast media allergy ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Food allergy ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hypersensitivity ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Seasonal allergy ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Infections and infestations
Abscess ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Acariasis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Arthritis infective ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Bacterial infection ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Biliary tract infection ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Bronchitis ^{* 1}
# participants affected / at risk	3/304 (0.99%)	1/309 (0.32%)
Candidiasis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Catheter site infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Cellulitis ^{* 1}
# participants affected / at risk	3/304 (0.99%)	4/309 (1.29%)
Cystitis ^{* 1}
# participants affected / at risk	4/304 (1.32%)	3/309 (0.97%)
Device related infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Enteritis infectious ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Erysipelas ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Escherichia infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Eye infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Fungal infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Furuncle ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Gastroenteritis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Infection ^{* 1}
# participants affected / at risk	4/304 (1.32%)	1/309 (0.32%)
Influenza ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Localised infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lower respiratory tract infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lung infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lymphangitis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Nasopharyngitis ^{* 1}
# participants affected / at risk	9/304 (2.96%)	7/309 (2.27%)
Oesophageal candidiasis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Oral candidiasis ^{* 1}
# participants affected / at risk	6/304 (1.97%)	5/309 (1.62%)
Oral fungal infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Oral herpes ^{* 1}
# participants affected / at risk	3/304 (0.99%)	1/309 (0.32%)
Oral infection ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Oropharyngeal candidiasis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Perichondritis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pharyngitis ^{* 1}
# participants affected / at risk	6/304 (1.97%)	0/309 (0.00%)
Pharyngotonsillitis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pneumonia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Pseudomonas infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Respiratory tract infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Rhinitis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	3/309 (0.97%)
Sepsis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Septic encephalopathy ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Septic shock ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Sinusitis ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Skin candida ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Tooth abscess ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Tooth infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Upper respiratory tract infection ^{* 1}
# participants affected / at risk	8/304 (2.63%)	2/309 (0.65%)
Urinary tract infection ^{* 1}
# participants affected / at risk	9/304 (2.96%)	11/309 (3.56%)
Viral infection ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Injury, poisoning and procedural complications
Anal injury ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Arthropod bite ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Burn oesophageal ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Contusion ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Drug toxicity ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Eschar ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Fall ^{* 1}
# participants affected / at risk	2/304 (0.66%)	2/309 (0.65%)
Feeding tube complication ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Humerus fracture ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Incision site pain ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Incisional hernia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Medication error ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Overdose ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Post procedural complication ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Post procedural haematoma ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Post procedural haemorrhage ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Postoperative wound complication ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Procedural pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Skin laceration ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Spinal compression fracture ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Wound ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Wound dehiscence ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Investigations
Activated partial thromboplastin time prolonged ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Alanine aminotransferase ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Alanine aminotransferase increased ^{* 1}
# participants affected / at risk	29/304 (9.54%)	24/309 (7.77%)
Ammonia increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Aspartate aminotransferase ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Aspartate aminotransferase increased ^{* 1}
# participants affected / at risk	24/304 (7.89%)	21/309 (6.80%)
Bacterial test positive ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Blood albumin decreased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Blood alkaline phosphatase ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Blood alkaline phosphatase increased ^{* 1}
# participants affected / at risk	15/304 (4.93%)	11/309 (3.56%)
Blood amylase increased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Blood bilirubin ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Blood bilirubin increased ^{* 1}
# participants affected / at risk	6/304 (1.97%)	9/309 (2.91%)
Blood creatinine increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	5/309 (1.62%)
Blood culture positive ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Blood fibrinogen increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Blood glucose decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Blood glucose increased ^{* 1}
# participants affected / at risk	3/304 (0.99%)	6/309 (1.94%)
Blood lactate dehydrogenase increased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Blood magnesium decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Blood potassium decreased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	3/309 (0.97%)
Blood potassium increased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Blood pressure increased ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Blood sodium decreased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Blood thyroid stimulating hormone decreased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Blood thyroid stimulating hormone increased ^{* 1}
# participants affected / at risk	16/304 (5.26%)	0/309 (0.00%)
Blood urea increased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Blood urine ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Blood urine present ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Body temperature increased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
C-reactive protein increased ^{* 1}
# participants affected / at risk	3/304 (0.99%)	3/309 (0.97%)
Eastern cooperative oncology group performance status worsened ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Electrocardiogram QRS complex abnormal ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Electrocardiogram QT prolonged ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Fibrin D dimer increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Gamma-glutamyltransferase increased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Haematocrit decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Haemoglobin ^{* 1}
# participants affected / at risk	0/304 (0.00%)	3/309 (0.97%)
Haemoglobin decreased ^{* 1}
# participants affected / at risk	18/304 (5.92%)	26/309 (8.41%)
International normalised ratio increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Liver function test abnormal ^{* 1}
# participants affected / at risk	4/304 (1.32%)	1/309 (0.32%)
Lymph node palpable ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lymphocyte count decreased ^{* 1}
# participants affected / at risk	6/304 (1.97%)	4/309 (1.29%)
Mean cell volume abnormal ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Monocyte count decreased ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Monocyte count increased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Monocyte percentage increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Neutrophil count ^{* 1}
# participants affected / at risk	5/304 (1.64%)	0/309 (0.00%)
Neutrophil count decreased ^{* 1}
# participants affected / at risk	31/304 (10.20%)	38/309 (12.30%)
Neutrophil percentage decreased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Oxygen saturation decreased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Platelet count ^{* 1}
# participants affected / at risk	4/304 (1.32%)	1/309 (0.32%)
Platelet count decreased ^{* 1}
# participants affected / at risk	43/304 (14.14%)	40/309 (12.94%)
Platelet count increased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Protein total decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Protein urine ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Protein urine present ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Prothrombin time abnormal ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Prothrombin time prolonged ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Prothrombin time shortened ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Red blood cell count decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Red cell distribution width increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Thyroxine free increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Transaminases increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Tri-iodothyronine free decreased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Tri-iodothyronine free increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Urine output decreased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Weight decreased ^{* 1}
# participants affected / at risk	44/304 (14.47%)	29/309 (9.39%)
Weight increased ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
White blood cell count ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
White blood cell count decreased ^{* 1}
# participants affected / at risk	20/304 (6.58%)	16/309 (5.18%)
Metabolism and nutrition disorders
Decreased appetite ^{* 1}
# participants affected / at risk	115/304 (37.83%)	87/309 (28.16%)
Dehydration ^{* 1}
# participants affected / at risk	5/304 (1.64%)	12/309 (3.88%)
Diabetes mellitus ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Fluid overload ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Gout ^{* 1}
# participants affected / at risk	3/304 (0.99%)	1/309 (0.32%)
Hyperammonaemia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hypercalcaemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hyperglycaemia ^{* 1}
# participants affected / at risk	9/304 (2.96%)	5/309 (1.62%)
Hyperkalaemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	3/309 (0.97%)
Hyperlipasaemia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hypernatraemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hyperuricaemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hypoalbuminaemia ^{* 1}
# participants affected / at risk	4/304 (1.32%)	5/309 (1.62%)
Hypocalcaemia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	4/309 (1.29%)
Hypoglycaemia ^{* 1}
# participants affected / at risk	2/304 (0.66%)	3/309 (0.97%)
Hypokalaemia ^{* 1}
# participants affected / at risk	13/304 (4.28%)	8/309 (2.59%)
Hypomagnesaemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Hyponatraemia ^{* 1}
# participants affected / at risk	4/304 (1.32%)	6/309 (1.94%)
Hypophosphataemia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Hypoproteinaemia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Lactic acidosis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Malnutrition ^{* 1}
# participants affected / at risk	2/304 (0.66%)	2/309 (0.65%)
Metabolic acidosis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{* 1}
# participants affected / at risk	10/304 (3.29%)	11/309 (3.56%)
Back pain ^{* 1}
# participants affected / at risk	34/304 (11.18%)	30/309 (9.71%)
Bone pain ^{* 1}
# participants affected / at risk	3/304 (0.99%)	2/309 (0.65%)
Bone swelling ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Flank pain ^{* 1}
# participants affected / at risk	2/304 (0.66%)	5/309 (1.62%)
Gouty arthritis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Intervertebral disc degeneration ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Joint swelling ^{* 1}
# participants affected / at risk	0/304 (0.00%)	4/309 (1.29%)
Muscle contracture ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Muscle spasms ^{* 1}
# participants affected / at risk	7/304 (2.30%)	3/309 (0.97%)
Muscle twitching ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Muscular weakness ^{* 1}
# participants affected / at risk	4/304 (1.32%)	3/309 (0.97%)
Musculoskeletal chest pain ^{* 1}
# participants affected / at risk	2/304 (0.66%)	7/309 (2.27%)
Musculoskeletal discomfort ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Musculoskeletal pain ^{* 1}
# participants affected / at risk	13/304 (4.28%)	7/309 (2.27%)
Musculoskeletal stiffness ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Myalgia ^{* 1}
# participants affected / at risk	11/304 (3.62%)	14/309 (4.53%)
Neck pain ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Osteoarthritis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Pain in extremity ^{* 1}
# participants affected / at risk	8/304 (2.63%)	11/309 (3.56%)
Pain in jaw ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Synovial cyst ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Torticollis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Trigger finger ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Upper extremity mass ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^{* 1}
# participants affected / at risk	8/304 (2.63%)	4/309 (1.29%)
Tumour associated fever ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Tumour pain ^{* 1}
# participants affected / at risk	2/304 (0.66%)	2/309 (0.65%)
Nervous system disorders
Ageusia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Amnesia ^{* 1}
# participants affected / at risk	3/304 (0.99%)	2/309 (0.65%)
Anaesthesia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Aphasia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Aphonia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Cognitive disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Cranial nerve disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Dizziness ^{* 1}
# participants affected / at risk	10/304 (3.29%)	17/309 (5.50%)
Dysaesthesia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Dysarthria ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Dysgeusia ^{* 1}
# participants affected / at risk	25/304 (8.22%)	14/309 (4.53%)
Extrapyramidal disorder ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Headache ^{* 1}
# participants affected / at risk	45/304 (14.80%)	26/309 (8.41%)
Hyperaesthesia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hypersomnia ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Hypoaesthesia ^{* 1}
# participants affected / at risk	6/304 (1.97%)	2/309 (0.65%)
Lethargy ^{* 1}
# participants affected / at risk	8/304 (2.63%)	12/309 (3.88%)
Loss of consciousness ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Memory impairment ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Metabolic encephalopathy ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Migraine ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Myoclonus ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Neuropathy peripheral ^{* 1}
# participants affected / at risk	3/304 (0.99%)	1/309 (0.32%)
Paraesthesia ^{* 1}
# participants affected / at risk	4/304 (1.32%)	4/309 (1.29%)
Peripheral sensory neuropathy ^{* 1}
# participants affected / at risk	3/304 (0.99%)	7/309 (2.27%)
Polyneuropathy ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Poor quality sleep ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Sciatica ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Sinus headache ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Somnolence ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Syncope ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Tremor ^{* 1}
# participants affected / at risk	3/304 (0.99%)	1/309 (0.32%)
Psychiatric disorders
Agitation ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Anxiety ^{* 1}
# participants affected / at risk	16/304 (5.26%)	19/309 (6.15%)
Aversion ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Confusional state ^{* 1}
# participants affected / at risk	7/304 (2.30%)	3/309 (0.97%)
Decreased activity ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Delirium ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Depression ^{* 1}
# participants affected / at risk	14/304 (4.61%)	10/309 (3.24%)
Dysphoria ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hallucination ^{* 1}
# participants affected / at risk	2/304 (0.66%)	3/309 (0.97%)
Hallucinations, mixed ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Insomnia ^{* 1}
# participants affected / at risk	25/304 (8.22%)	18/309 (5.83%)
Loss of libido ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Nightmare ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Paranoia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Sleep disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Vomiting psychogenic ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Renal and urinary disorders
Bladder pain ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Chromaturia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Dysuria ^{* 1}
# participants affected / at risk	5/304 (1.64%)	1/309 (0.32%)
Haematuria ^{* 1}
# participants affected / at risk	4/304 (1.32%)	4/309 (1.29%)
Hydronephrosis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Micturition urgency ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pollakiuria ^{* 1}
# participants affected / at risk	4/304 (1.32%)	3/309 (0.97%)
Polyuria ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Proteinuria ^{* 1}
# participants affected / at risk	17/304 (5.59%)	12/309 (3.88%)
Pyuria ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Renal failure acute ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Renal impairment ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Urethral pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Urinary incontinence ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Reproductive system and breast disorders
Breast enlargement ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Genital haemorrhage ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Menopausal symptoms ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Metrorrhagia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Prostatism ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pruritus genital ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Scrotal ulcer ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Vaginal haemorrhage ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Vulvovaginal dryness ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Vulvovaginal pruritus ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Respiratory, thoracic and mediastinal disorders
Asphyxia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Asthma ^{* 1}
# participants affected / at risk	0/304 (0.00%)	2/309 (0.65%)
Atelectasis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Cough ^{* 1}
# participants affected / at risk	24/304 (7.89%)	19/309 (6.15%)
Dry throat ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Dysphonia ^{* 1}
# participants affected / at risk	68/304 (22.37%)	12/309 (3.88%)
Dyspnoea ^{* 1}
# participants affected / at risk	24/304 (7.89%)	20/309 (6.47%)
Dyspnoea exertional ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Epistaxis ^{* 1}
# participants affected / at risk	14/304 (4.61%)	7/309 (2.27%)
Haemoptysis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Hiccups ^{* 1}
# participants affected / at risk	6/304 (1.97%)	3/309 (0.97%)
Hypoxia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	3/309 (0.97%)
Interstitial lung disease ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Laryngeal oedema ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Nasal congestion ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Nasal dryness ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Nasal mucosal disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Nasal ulcer ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Oropharyngeal discomfort ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Oropharyngeal pain ^{* 1}
# participants affected / at risk	12/304 (3.95%)	1/309 (0.32%)
Painful respiration ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pharyngeal oedema ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pleural effusion ^{* 1}
# participants affected / at risk	0/304 (0.00%)	6/309 (1.94%)
Pneumothorax ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Productive cough ^{* 1}
# participants affected / at risk	3/304 (0.99%)	2/309 (0.65%)
Pulmonary congestion ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pulmonary embolism ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Pulmonary hypertension ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Pulmonary oedema ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Rales ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Rhinalgia ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Rhinitis allergic ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Rhinorrhoea ^{* 1}
# participants affected / at risk	4/304 (1.32%)	2/309 (0.65%)
Sinus congestion ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Sputum increased ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Upper-airway cough syndrome ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Wheezing ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Skin and subcutaneous tissue disorders
Acne ^{* 1}
# participants affected / at risk	4/304 (1.32%)	1/309 (0.32%)
Alopecia ^{* 1}
# participants affected / at risk	31/304 (10.20%)	20/309 (6.47%)
Circumoral oedema ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Cold sweat ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Decubitus ulcer ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Dermatitis ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Dermatitis acneiform ^{* 1}
# participants affected / at risk	4/304 (1.32%)	0/309 (0.00%)
Dermatitis allergic ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Dermatitis contact ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Dry skin ^{* 1}
# participants affected / at risk	7/304 (2.30%)	2/309 (0.65%)
Eczema ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Erythema ^{* 1}
# participants affected / at risk	3/304 (0.99%)	5/309 (1.62%)
Hair texture abnormal ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Heat rash ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Hyperhidrosis ^{* 1}
# participants affected / at risk	3/304 (0.99%)	3/309 (0.97%)
Increased tendency to bruise ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Nail bed bleeding ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Nail bed inflammation ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Nail disorder ^{* 1}
# participants affected / at risk	5/304 (1.64%)	1/309 (0.32%)
Night sweats ^{* 1}
# participants affected / at risk	3/304 (0.99%)	9/309 (2.91%)
Pain of skin ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Palmar-plantar erythrodysaesthesia syndrome ^{* 1}
# participants affected / at risk	18/304 (5.92%)	2/309 (0.65%)
Petechiae ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Pigmentation disorder ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Pruritus ^{* 1}
# participants affected / at risk	14/304 (4.61%)	17/309 (5.50%)
Pruritus generalised ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Rash ^{* 1}
# participants affected / at risk	43/304 (14.14%)	41/309 (13.27%)
Rash erythematous ^{* 1}
# participants affected / at risk	3/304 (0.99%)	0/309 (0.00%)
Rash generalised ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Rash macular ^{* 1}
# participants affected / at risk	1/304 (0.33%)	3/309 (0.97%)
Rash papular ^{* 1}
# participants affected / at risk	2/304 (0.66%)	1/309 (0.32%)
Rash pruritic ^{* 1}
# participants affected / at risk	1/304 (0.33%)	4/309 (1.29%)
Scab ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Skin exfoliation ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Skin fissures ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Skin hyperpigmentation ^{* 1}
# participants affected / at risk	3/304 (0.99%)	2/309 (0.65%)
Skin induration ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Skin irritation ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Skin lesion ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Skin nodule ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Skin reaction ^{* 1}
# participants affected / at risk	10/304 (3.29%)	1/309 (0.32%)
Skin toxicity ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Subcutaneous nodule ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Swelling face ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Urticaria ^{* 1}
# participants affected / at risk	4/304 (1.32%)	1/309 (0.32%)
Surgical and medical procedures
Abdominal cavity drainage ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Vascular disorders
Angiopathy ^{* 1}
# participants affected / at risk	1/304 (0.33%)	2/309 (0.65%)
Deep vein thrombosis ^{* 1}
# participants affected / at risk	4/304 (1.32%)	9/309 (2.91%)
Flushing ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Haemorrhage ^{* 1}
# participants affected / at risk	1/304 (0.33%)	1/309 (0.32%)
Hot flush ^{* 1}
# participants affected / at risk	5/304 (1.64%)	1/309 (0.32%)
Hypertension ^{* 1}
# participants affected / at risk	84/304 (27.63%)	26/309 (8.41%)
Hypotension ^{* 1}
# participants affected / at risk	9/304 (2.96%)	14/309 (4.53%)
Orthostatic hypotension ^{* 1}
# participants affected / at risk	2/304 (0.66%)	0/309 (0.00%)
Pallor ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)
Phlebitis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	5/309 (1.62%)
Phlebitis superficial ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Thrombophlebitis ^{* 1}
# participants affected / at risk	0/304 (0.00%)	3/309 (0.97%)
Thrombophlebitis superficial ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Thrombosis ^{* 1}
# participants affected / at risk	2/304 (0.66%)	3/309 (0.97%)
Vein pain ^{* 1}
# participants affected / at risk	0/304 (0.00%)	1/309 (0.32%)
Venous thrombosis ^{* 1}
# participants affected / at risk	1/304 (0.33%)	0/309 (0.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA v13.1

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

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Publications automatically indexed to this study:

Kindler HL, Ioka T, Richel DJ, Bennouna J, Létourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00471146 History of Changes
Other Study ID Numbers:	A4061028
Study First Received:	May 7, 2007
Results First Received:	February 25, 2012
Last Updated:	June 14, 2012
Health Authority:	United States: Food and Drug Administration

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