Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00716625
• Collaborator: (none)
• Enrollment: 1,674
• Duration (Months): 88

Study Details

Study Description

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: sunitinib malate

Detailed Description

All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.

Study Design

• Study Type: Observational
• Actual Enrollment: 1674 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

sunitinib malate Patients taking sunitinib malate

Drug: sunitinib malate; SUTENT® Capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated. The dosage may be decreased according to the patient's clinical condition."; Other Names: Sutent

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

2. Objective Response Rate [MAX 2 Years]

   Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).

Secondary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events in Pediatric Population [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.

2. Number of Participants With Treatment-Related Adverse Events in Elderly Population [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.

3. Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.

4. Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.

5. Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.

6. Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.

7. Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation [MAX 2 Years]

   The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

Other Outcome Measures

1. Number of Participants With Treatment-Related Serious Adverse Events [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

3. Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE) [MAX 2 Years]

   A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

• Patients not administered sunitinib malate (Sutent).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00716625
• Other Study ID Numbers: A6181176
• First Posted: Jul 16, 2008
• Last Update Posted: Jan 18, 2017
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Period Title: Overall Study
STARTED	1674
COMPLETED	1673
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Overall Participants	1673
Age, Customized (Number) [Number]
<15 years	1 0.1%
>=15 and <65 years	940 56.2%
˃=65 years	712 42.6%
Unknown	20 1.2%
Gender (Count of Participants)
Female	421 25.2%
Male	1252 74.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1673
Number [Participants]	1599 95.6%

2. Primary Outcome

Title	Objective Response Rate
Description	Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1430
Number (95% Confidence Interval) [Percentage of participants]	21.9 1.3%

3. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events in Pediatric Population
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Pediatric	Adult	Unknown
Arm/Group Description	Participants aged ˂15 years who received sunitinib malate according to Japanese package insert	Participants aged ˃=15 years who received sunitinib malate according to Japanese package insert	Participants with unknown age who received sunitinib malate according to Japanese package insert
Measure Participants	1	1652	20
Number [Participants]	1 0.1%	1581 NaN	17 NaN

4. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events in Elderly Population
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Elderly	Non-elderly	Unknown
Arm/Group Description	Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert	Participants aged ˂65 years who received sunitinib malate according to Japanese package insert	Participants with unknown age who received sunitinib malate according to Japanese package insert
Measure Participants	712	941	20
Number [Participants]	688 41.1%	894 NaN	17 NaN

5. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	With Hepatic Impairment	Without Hepatic Impairment	Unknown
Arm/Group Description	Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert	Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert	Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
Measure Participants	162	1506	5
Number [Participants]	154 9.2%	1441 NaN	4 NaN

6. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	With Renal Impairment	Without Renal Impairment	Unknown
Arm/Group Description	Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert	Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert	Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
Measure Participants	347	1322	4
Number [Participants]	336 20.1%	1260 NaN	3 NaN

7. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	With Concomitant CYP3A4 Inhibitors (Start of Treatment)	With Concomitant CYP3A4 Inhibitors (During Treatment)	Without Concomitant CYP3A4 Inhibitors
Arm/Group Description	Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert	Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert	Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
Measure Participants	82	45	1546
Number [Participants]	82 4.9%	45 NaN	1472 NaN

8. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1673
Number [Participants]	4 0.2%

9. Secondary Outcome

Title	Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
Description	The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1673
Lung disorder	19 1.1%
Bone marrow depression	1294 77.3%
Haemorrhage	287 17.2%
Cardiac function disturbance	61 3.6%
Dysfunction adrenal	6 0.4%
Pancreatic dysfunction	313 18.7%
Thyroid function decreased	700 41.8%
Cutaneous symptoms (hand and foot syndrome)	629 37.6%
Serious infections	63 3.8%
Rhabdomyolysis, myopathy	24 1.4%
RPLS	3 0.2%

10. Other Pre-specified Outcome

Title	Number of Participants With Treatment-Related Serious Adverse Events
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1673
Number [Participants]	793 47.4%

11. Other Pre-specified Outcome

Title	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1673
Number [Participants]	352 21%

12. Other Pre-specified Outcome

Title	Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)
Description	A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.
Time Frame	MAX 2 Years

Outcome Measure Data

Analysis Population Description

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
Measure Participants	1673
Number [Participants]	1194 71.4%

Adverse Events

Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Sunitinib Malate
Arm/Group Description	Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
All Cause Mortality
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	1000/1673 (59.8%)
Blood and lymphatic system disorders
Anaemia	56/1673 (3.3%)
Disseminated intravascular coagulation	24/1673 (1.4%)
Eosinophilia	1/1673 (0.1%)
Febrile neutropenia	2/1673 (0.1%)
Leukopenia	8/1673 (0.5%)
Lymphopenia	2/1673 (0.1%)
Neutropenia	18/1673 (1.1%)
Pancytopenia	2/1673 (0.1%)
Thrombocytopenia	48/1673 (2.9%)
Thrombotic microangiopathy	1/1673 (0.1%)
Haemorrhagic anaemia	1/1673 (0.1%)
Nephrogenic anaemia	1/1673 (0.1%)
Bone marrow failure	29/1673 (1.7%)
Immune thrombocytopenic purpura	1/1673 (0.1%)
Cardiac disorders
Acute myocardial infarction	1/1673 (0.1%)
Atrial fibrillation	2/1673 (0.1%)
Atrioventricular block	1/1673 (0.1%)
Cardiac arrest	1/1673 (0.1%)
Cardiac failure	6/1673 (0.4%)
Cardiac failure congestive	4/1673 (0.2%)
Cardio-respiratory arrest	1/1673 (0.1%)
Myocardial infarction	1/1673 (0.1%)
Myocardial ischaemia	1/1673 (0.1%)
Pericardial effusion	3/1673 (0.2%)
Sinus bradycardia	1/1673 (0.1%)
Supraventricular tachycardia	1/1673 (0.1%)
Ventricular fibrillation	1/1673 (0.1%)
Left ventricular dysfunction	2/1673 (0.1%)
Cardiac disorder	1/1673 (0.1%)
Endocrine disorders
Adrenal haemorrhage	1/1673 (0.1%)
Adrenal insufficiency	1/1673 (0.1%)
Adrenocortical insufficiency acute	2/1673 (0.1%)
Hyperthyroidism	6/1673 (0.4%)
Hypothyroidism	52/1673 (3.1%)
Thyroid disorder	2/1673 (0.1%)
Thyroiditis	1/1673 (0.1%)
Inappropriate antidiuretic hormone secretion	1/1673 (0.1%)
Myxoedema	1/1673 (0.1%)
Eye disorders
Vision blurred	1/1673 (0.1%)
Vitreous haemorrhage	2/1673 (0.1%)
Ulcerative keratitis	1/1673 (0.1%)
Gastrointestinal disorders
Abdominal discomfort	1/1673 (0.1%)
Abdominal distension	1/1673 (0.1%)
Abdominal pain	4/1673 (0.2%)
Ascites	4/1673 (0.2%)
Colitis ulcerative	1/1673 (0.1%)
Diarrhoea	26/1673 (1.6%)
Diverticulum intestinal haemorrhagic	1/1673 (0.1%)
Dry mouth	1/1673 (0.1%)
Duodenal perforation	1/1673 (0.1%)
Duodenal ulcer	1/1673 (0.1%)
Dyspepsia	1/1673 (0.1%)
Dysphagia	1/1673 (0.1%)
Gastric perforation	1/1673 (0.1%)
Gastric ulcer	2/1673 (0.1%)
Gastric ulcer haemorrhage	1/1673 (0.1%)
Gastrooesophageal reflux disease	3/1673 (0.2%)
Gastrointestinal haemorrhage	18/1673 (1.1%)
Gastrointestinal perforation	5/1673 (0.3%)
Gingival bleeding	1/1673 (0.1%)
Glossitis	1/1673 (0.1%)
Glossodynia	1/1673 (0.1%)
Haematemesis	1/1673 (0.1%)
Ileus	7/1673 (0.4%)
Ileus paralytic	1/1673 (0.1%)
Intestinal obstruction	4/1673 (0.2%)
Intestinal perforation	5/1673 (0.3%)
Large intestine perforation	1/1673 (0.1%)
Mallory-Weiss syndrome	1/1673 (0.1%)
Melaena	3/1673 (0.2%)
Mouth haemorrhage	1/1673 (0.1%)
Nausea	18/1673 (1.1%)
Oesophageal ulcer	1/1673 (0.1%)
Oesophagitis	2/1673 (0.1%)
Pancreatic enzyme abnormality	7/1673 (0.4%)
Pancreatitis	2/1673 (0.1%)
Pancreatitis acute	1/1673 (0.1%)
Parotid gland enlargement	1/1673 (0.1%)
Peptic ulcer	1/1673 (0.1%)
Rectal haemorrhage	2/1673 (0.1%)
Rectal ulcer	2/1673 (0.1%)
Stomatitis	12/1673 (0.7%)
Upper gastrointestinal haemorrhage	2/1673 (0.1%)
Vomiting	10/1673 (0.6%)
Gastroduodenitis	1/1673 (0.1%)
Small intestinal haemorrhage	3/1673 (0.2%)
Pneumatosis intestinalis	3/1673 (0.2%)
Diverticular perforation	2/1673 (0.1%)
General disorders
Asthenia	3/1673 (0.2%)
Death	14/1673 (0.8%)
Face oedema	1/1673 (0.1%)
Fatigue	11/1673 (0.7%)
Generalised oedema	2/1673 (0.1%)
Impaired healing	1/1673 (0.1%)
Malaise	37/1673 (2.2%)
Multi-organ failure	3/1673 (0.2%)
Oedema	8/1673 (0.5%)
Oedema peripheral	1/1673 (0.1%)
Pain	3/1673 (0.2%)
Pyrexia	55/1673 (3.3%)
Sudden death	1/1673 (0.1%)
Localised oedema	1/1673 (0.1%)
General physical health deterioration	2/1673 (0.1%)
Induration	1/1673 (0.1%)
Disease progression	187/1673 (11.2%)
Hepatobiliary disorders
Bile duct stone	1/1673 (0.1%)
Cholangitis	2/1673 (0.1%)
Cholecystitis	5/1673 (0.3%)
Cholecystitis acute	6/1673 (0.4%)
Cholelithiasis	1/1673 (0.1%)
Hepatic failure	3/1673 (0.2%)
Hepatic function abnormal	45/1673 (2.7%)
Hyperbilirubinaemia	2/1673 (0.1%)
Jaundice	2/1673 (0.1%)
Liver disorder	4/1673 (0.2%)
Bile duct obstruction	1/1673 (0.1%)
Drug-induced liver injury	2/1673 (0.1%)
Infections and infestations
Acute tonsillitis	1/1673 (0.1%)
Appendicitis	2/1673 (0.1%)
Bronchitis	1/1673 (0.1%)
Epididymitis	1/1673 (0.1%)
Gastroenteritis	1/1673 (0.1%)
Gingivitis	6/1673 (0.4%)
Hepatitis infectious	1/1673 (0.1%)
Herpes zoster	4/1673 (0.2%)
Infection	10/1673 (0.6%)
Liver abscess	1/1673 (0.1%)
Lung abscess	1/1673 (0.1%)
Periodontitis	3/1673 (0.2%)
Pharyngitis	1/1673 (0.1%)
Pneumonia	27/1673 (1.6%)
Postoperative wound infection	1/1673 (0.1%)
Pseudomembranous colitis	1/1673 (0.1%)
Pulmonary tuberculosis	2/1673 (0.1%)
Pyelonephritis	2/1673 (0.1%)
Pyelonephritis acute	1/1673 (0.1%)
Sepsis	5/1673 (0.3%)
Septic shock	1/1673 (0.1%)
Sinusitis	1/1673 (0.1%)
Tooth abscess	1/1673 (0.1%)
Urinary tract infection	1/1673 (0.1%)
Anal abscess	2/1673 (0.1%)
Streptococcal sepsis	1/1673 (0.1%)
Peritonsillitis	1/1673 (0.1%)
Appendiceal abscess	1/1673 (0.1%)
Enteritis infectious	2/1673 (0.1%)
Neutropenic infection	3/1673 (0.2%)
Pneumonia bacterial	3/1673 (0.2%)
Cholecystitis infective	1/1673 (0.1%)
Device related infection	1/1673 (0.1%)
Alveolar osteitis	1/1673 (0.1%)
Infectious pleural effusion	2/1673 (0.1%)
Peritonitis	7/1673 (0.4%)
Injury, poisoning and procedural complications
Accident	1/1673 (0.1%)
Brain herniation	1/1673 (0.1%)
Femoral neck fracture	3/1673 (0.2%)
Femur fracture	2/1673 (0.1%)
Humerus fracture	1/1673 (0.1%)
Wound dehiscence	1/1673 (0.1%)
Lumbar vertebral fracture	3/1673 (0.2%)
Brain contusion	1/1673 (0.1%)
Thermal burn	1/1673 (0.1%)
Lower limb fracture	1/1673 (0.1%)
Investigations
Alanine aminotransferase increased	15/1673 (0.9%)
Aspartate aminotransferase increased	19/1673 (1.1%)
Blood albumin decreased	1/1673 (0.1%)
Blood bilirubin increased	3/1673 (0.2%)
Blood creatine phosphokinase increased	4/1673 (0.2%)
Blood creatinine increased	15/1673 (0.9%)
Blood lactate dehydrogenase increased	2/1673 (0.1%)
Blood potassium increased	2/1673 (0.1%)
Blood pressure decreased	1/1673 (0.1%)
Blood pressure increased	1/1673 (0.1%)
Blood sodium decreased	1/1673 (0.1%)
Blood thyroid stimulating hormone increased	2/1673 (0.1%)
Blood urea increased	1/1673 (0.1%)
Blood uric acid increased	3/1673 (0.2%)
C-reactive protein increased	7/1673 (0.4%)
Electrocardiogram T wave inversion	1/1673 (0.1%)
Haemoglobin decreased	15/1673 (0.9%)
Lipase increased	19/1673 (1.1%)
Lymphocyte count decreased	10/1673 (0.6%)
Neutrophil count decreased	54/1673 (3.2%)
Platelet count decreased	334/1673 (20%)
Prothrombin time prolonged	1/1673 (0.1%)
Weight increased	1/1673 (0.1%)
White blood cell count decreased	95/1673 (5.7%)
Ejection fraction decreased	13/1673 (0.8%)
Blood creatine phosphokinase BB increased	1/1673 (0.1%)
Protein urine present	1/1673 (0.1%)
Troponin increased	1/1673 (0.1%)
Cardiac function test abnormal	1/1673 (0.1%)
Blood alkaline phosphatase increased	7/1673 (0.4%)
Hepatic enzyme increased	1/1673 (0.1%)
Pancreatic enzymes increased	2/1673 (0.1%)
Cell marker increased	1/1673 (0.1%)
Amylase increased	11/1673 (0.7%)
Haematocrit decreased	1/1673 (0.1%)
Metabolism and nutrition disorders
Acidosis	1/1673 (0.1%)
Cachexia	2/1673 (0.1%)
Dehydration	9/1673 (0.5%)
Diabetes mellitus	1/1673 (0.1%)
Electrolyte imbalance	1/1673 (0.1%)
Fluid retention	1/1673 (0.1%)
Hypercalcaemia	10/1673 (0.6%)
Hyperkalaemia	12/1673 (0.7%)
Hyperuricaemia	6/1673 (0.4%)
Hypoalbuminaemia	10/1673 (0.6%)
Hypocalcaemia	3/1673 (0.2%)
Hyponatraemia	19/1673 (1.1%)
Hypophosphataemia	3/1673 (0.2%)
Hypoproteinaemia	2/1673 (0.1%)
Tumour lysis syndrome	2/1673 (0.1%)
Feeding disorder	1/1673 (0.1%)
Decreased appetite	44/1673 (2.6%)
Hyperlipidaemia	2/1673 (0.1%)
Hyperamylasaemia	1/1673 (0.1%)
Hypophagia	3/1673 (0.2%)
Hyperlipasaemia	1/1673 (0.1%)
Musculoskeletal and connective tissue disorders
Flank pain	1/1673 (0.1%)
Muscular weakness	4/1673 (0.2%)
Myalgia	1/1673 (0.1%)
Myopathy	1/1673 (0.1%)
Osteitis	1/1673 (0.1%)
Pain in extremity	2/1673 (0.1%)
Pathological fracture	1/1673 (0.1%)
Rhabdomyolysis	1/1673 (0.1%)
Intervertebral disc protrusion	1/1673 (0.1%)
Osteonecrosis of jaw	1/1673 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer	3/1673 (0.2%)
Intracranial tumour haemorrhage	1/1673 (0.1%)
Lymphoma	1/1673 (0.1%)
Malignant pleural effusion	4/1673 (0.2%)
Metastases to bone	1/1673 (0.1%)
Metastases to liver	1/1673 (0.1%)
Metastases to lung	1/1673 (0.1%)
Metastases to lymph nodes	1/1673 (0.1%)
Neoplasm malignant	1/1673 (0.1%)
Tumour haemorrhage	5/1673 (0.3%)
Lymphangiosis carcinomatosa	4/1673 (0.2%)
Cancer pain	2/1673 (0.1%)
Metastases to central nervous system	8/1673 (0.5%)
Pleural neoplasm	1/1673 (0.1%)
Plasma cell myeloma	1/1673 (0.1%)
Neoplasm progression	23/1673 (1.4%)
Nervous system disorders
Altered state of consciousness	8/1673 (0.5%)
Cerebellar haemorrhage	1/1673 (0.1%)
Cerebral haemorrhage	15/1673 (0.9%)
Cerebral infarction	9/1673 (0.5%)
Depressed level of consciousness	3/1673 (0.2%)
Diplegia	2/1673 (0.1%)
Dizziness	4/1673 (0.2%)
Dizziness postural	1/1673 (0.1%)
Dysgeusia	2/1673 (0.1%)
Encephalopathy	1/1673 (0.1%)
Epilepsy	1/1673 (0.1%)
Guillain-Barre syndrome	1/1673 (0.1%)
Headache	2/1673 (0.1%)
Hemiparesis	1/1673 (0.1%)
Hemiplegia	2/1673 (0.1%)
Hypoaesthesia	1/1673 (0.1%)
Intracranial pressure increased	1/1673 (0.1%)
Loss of consciousness	1/1673 (0.1%)
Monoplegia	2/1673 (0.1%)
Myasthenia gravis	1/1673 (0.1%)
Myoclonus	1/1673 (0.1%)
Nervous system disorder	1/1673 (0.1%)
Neuralgia	1/1673 (0.1%)
Paraplegia	1/1673 (0.1%)
Tremor	1/1673 (0.1%)
Brain oedema	3/1673 (0.2%)
Balance disorder	1/1673 (0.1%)
VIIth nerve paralysis	1/1673 (0.1%)
Lacunar infarction	1/1673 (0.1%)
Metabolic encephalopathy	1/1673 (0.1%)
Posterior reversible encephalopathy syndrome	3/1673 (0.2%)
Seizure	1/1673 (0.1%)
Psychiatric disorders
Completed suicide	1/1673 (0.1%)
Delirium	1/1673 (0.1%)
Depression	1/1673 (0.1%)
Mood swings	1/1673 (0.1%)
Suicide attempt	1/1673 (0.1%)
Renal and urinary disorders
Dysuria	1/1673 (0.1%)
Haematuria	2/1673 (0.1%)
Nephrosclerosis	1/1673 (0.1%)
Nephrotic syndrome	5/1673 (0.3%)
Proteinuria	4/1673 (0.2%)
Renal disorder	1/1673 (0.1%)
Renal failure	2/1673 (0.1%)
Renal haemorrhage	1/1673 (0.1%)
Urinary retention	2/1673 (0.1%)
Haemorrhage urinary tract	2/1673 (0.1%)
Postrenal failure	1/1673 (0.1%)
Renal impairment	22/1673 (1.3%)
Bladder tamponade	1/1673 (0.1%)
Chronic kidney disease	1/1673 (0.1%)
Acute kidney injury	5/1673 (0.3%)
Reproductive system and breast disorders
Scrotal ulcer	1/1673 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/1673 (0.1%)
Aspiration	1/1673 (0.1%)
Bronchial obstruction	1/1673 (0.1%)
Dyspnoea	4/1673 (0.2%)
Epistaxis	10/1673 (0.6%)
Haemoptysis	7/1673 (0.4%)
Haemothorax	2/1673 (0.1%)
Hypoxia	1/1673 (0.1%)
Interstitial lung disease	16/1673 (1%)
Pleural effusion	26/1673 (1.6%)
Pneumonia aspiration	3/1673 (0.2%)
Pneumonitis	1/1673 (0.1%)
Pneumothorax	3/1673 (0.2%)
Pulmonary alveolar haemorrhage	1/1673 (0.1%)
Pulmonary embolism	2/1673 (0.1%)
Pulmonary oedema	1/1673 (0.1%)
Respiratory arrest	1/1673 (0.1%)
Respiratory failure	5/1673 (0.3%)
Obstructive airways disorder	2/1673 (0.1%)
Organising pneumonia	1/1673 (0.1%)
Oropharyngeal pain	1/1673 (0.1%)
Laryngeal pain	1/1673 (0.1%)
Pneumothorax spontaneous	1/1673 (0.1%)
Skin and subcutaneous tissue disorders
Erythema multiforme	2/1673 (0.1%)
Haemorrhage subcutaneous	1/1673 (0.1%)
Palmar-plantar erythrodysaesthesia syndrome	24/1673 (1.4%)
Purpura	1/1673 (0.1%)
Pyoderma gangrenosum	1/1673 (0.1%)
Rash	5/1673 (0.3%)
Skin disorder	1/1673 (0.1%)
Urticaria	2/1673 (0.1%)
Vascular disorders
Aortic dissection	3/1673 (0.2%)
Circulatory collapse	2/1673 (0.1%)
Flushing	1/1673 (0.1%)
Hypertension	55/1673 (3.3%)
Hypotension	1/1673 (0.1%)
Shock	1/1673 (0.1%)
Venous thrombosis	1/1673 (0.1%)
Aneurysm ruptured	1/1673 (0.1%)
Deep vein thrombosis	1/1673 (0.1%)
Vascular insufficiency	1/1673 (0.1%)
Haemorrhage	5/1673 (0.3%)
Artery dissection	1/1673 (0.1%)
Other (Not Including Serious) Adverse Events
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	1530/1673 (91.5%)
Blood and lymphatic system disorders
Anaemia	170/1673 (10.2%)
Thrombocytopenia	109/1673 (6.5%)
Bone marrow failure	54/1673 (3.2%)
Leukopenia	50/1673 (3%)
Neutropenia	23/1673 (1.4%)
Endocrine disorders
Hypothyroidism	589/1673 (35.2%)
Hyperthyroidism	40/1673 (2.4%)
Thyroid disorder	23/1673 (1.4%)
Eye disorders
Eyelid oedema	24/1673 (1.4%)
Gastrointestinal disorders
Constipation	102/1673 (6.1%)
Diarrhoea	284/1673 (17%)
Nausea	153/1673 (9.1%)
Stomatitis	285/1673 (17%)
Abdominal discomfort	38/1673 (2.3%)
Abdominal pain	19/1673 (1.1%)
Abdominal pain upper	22/1673 (1.3%)
Cheilitis	27/1673 (1.6%)
Dyspepsia	47/1673 (2.8%)
Gastritis	52/1673 (3.1%)
Gastrooesophageal reflux disease	19/1673 (1.1%)
Gingival bleeding	20/1673 (1.2%)
Vomiting	79/1673 (4.7%)
Pancreatic enzyme abnormality	29/1673 (1.7%)
Gastric ulcer	27/1673 (1.6%)
General disorders
Malaise	176/1673 (10.5%)
Oedema	91/1673 (5.4%)
Pyrexia	211/1673 (12.6%)
Face oedema	44/1673 (2.6%)
Fatigue	73/1673 (4.4%)
Oedema peripheral	31/1673 (1.9%)
Hepatobiliary disorders
Hepatic function abnormal	163/1673 (9.7%)
Liver disorder	22/1673 (1.3%)
Infections and infestations
Gingivitis	30/1673 (1.8%)
Nasopharyngitis	25/1673 (1.5%)
Periodontitis	23/1673 (1.4%)
Pneumonia	19/1673 (1.1%)
Investigations
Aspartate aminotransferase increased	91/1673 (5.4%)
Haemoglobin decreased	85/1673 (5.1%)
Lipase increased	179/1673 (10.7%)
Neutrophil count decreased	176/1673 (10.5%)
Platelet count decreased	694/1673 (41.5%)
White blood cell count decreased	464/1673 (27.7%)
Amylase increased	120/1673 (7.2%)
C-reactive protein increased	25/1673 (1.5%)
Alanine aminotransferase increased	64/1673 (3.8%)
Lymphocyte count decreased	39/1673 (2.3%)
Ejection fraction decreased	19/1673 (1.1%)
Blood pressure increased	31/1673 (1.9%)
Blood alkaline phosphatase increased	38/1673 (2.3%)
Blood creatinine increased	55/1673 (3.3%)
Blood creatine phosphokinase increased	21/1673 (1.3%)
Blood bilirubin increased	18/1673 (1.1%)
Blood thyroid stimulating hormone increased	51/1673 (3%)
Blood lactate dehydrogenase increased	23/1673 (1.4%)
Metabolism and nutrition disorders
Decreased appetite	196/1673 (11.7%)
Hyperkalaemia	23/1673 (1.4%)
Hyperuricaemia	65/1673 (3.9%)
Hypoalbuminaemia	19/1673 (1.1%)
Hyponatraemia	20/1673 (1.2%)
Musculoskeletal and connective tissue disorders
Back pain	30/1673 (1.8%)
Nervous system disorders
Dysgeusia	139/1673 (8.3%)
Headache	37/1673 (2.2%)
Psychiatric disorders
Insomnia	51/1673 (3%)
Renal and urinary disorders
Haematuria	22/1673 (1.3%)
Renal impairment	64/1673 (3.8%)
Proteinuria	19/1673 (1.1%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	105/1673 (6.3%)
Cough	26/1673 (1.6%)
Pleural effusion	27/1673 (1.6%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome	603/1673 (36%)
Rash	103/1673 (6.2%)
Alopecia	19/1673 (1.1%)
Eczema	18/1673 (1.1%)
Erythema	23/1673 (1.4%)
Pruritus	18/1673 (1.1%)
Skin discolouration	25/1673 (1.5%)
Skin disorder	24/1673 (1.4%)
Yellow skin	57/1673 (3.4%)
Vascular disorders
Hypertension	551/1673 (32.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.