Trial Outcomes & Findings for Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer (NCT NCT00465179)
NCT ID: NCT00465179
Last Updated: 2016-06-07
Results Overview
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years
Results posted on
2016-06-07
Participant Flow
All participants were enrolled between March 2007 and August 2010 at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
61 participants were enrolled to the study. 4 participants did not receive any treatment, resulting in 57 participants available for evaluation.
Participant milestones
| Measure |
Sunitinib Malate
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Sunitinib Malate
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Progression of Disease
|
47
|
Baseline Characteristics
Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib Malate
n=57 Participants
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 yearsPopulation: Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Sunitinib Malate
n=55 Participants
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Number of Participants With Response to Treatment
Complete Response
|
0 participants
|
|
Number of Participants With Response to Treatment
Partial Response
|
3 participants
|
|
Number of Participants With Response to Treatment
Stable Disease
|
29 participants
|
|
Number of Participants With Response to Treatment
Progressive Disease
|
23 participants
|
PRIMARY outcome
Timeframe: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 yearsPopulation: Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.
Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.
Outcome measures
| Measure |
Sunitinib Malate
n=55 Participants
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Median Progression-Free Survival (PFS)
|
2.7 months
Interval 1.4 to 5.4
|
SECONDARY outcome
Timeframe: Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.Overall survival was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Sunitinib Malate
n=57 Participants
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Median Overall Survival
|
16.8 months
Interval 10.7 to 26.3
|
Adverse Events
Sunitinib Malate
Serious events: 57 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib Malate
n=57 participants at risk
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
General disorders
Fatigue
|
28.1%
16/57 • Number of events 16 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Hypertension
|
28.1%
16/57 • Number of events 16 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.3%
11/57 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Pain
|
12.3%
7/57 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
10.5%
6/57 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.8%
5/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Anemia
|
8.8%
5/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Sensory Neuropathy
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Anorexia
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Motor Neuropathy
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Vascular disorders
Hemorrhage
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Nonneutropenic Fever
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Left Ventricular Diastolic Dysfunction
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Hepatobiliary disorders
Transaminitis
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Elevated Lipase
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Myocardial Infarct
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Thrombosis/Embolism
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Infections and infestations
Febrile Neutropenia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Syncope
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Dehydration
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Death
|
68.4%
39/57 • Number of events 39 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Sickle-Thalassemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
Other adverse events
| Measure |
Sunitinib Malate
n=57 participants at risk
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Activated Partial Thromboplastin Time Prolonged
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
19/57 • Number of events 44 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
35.1%
20/57 • Number of events 33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Immune system disorders
Allergic Rhinitis
|
3.5%
2/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Immune system disorders
Allergy/Immunology-Other
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Alanine Aminotransferase
|
29.8%
17/57 • Number of events 21 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Amylase
|
12.3%
7/57 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Anemia
|
3.5%
2/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Anorexia
|
29.8%
17/57 • Number of events 23 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Aspartate Transaminase
|
54.4%
31/57 • Number of events 50 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Immune system disorders
Autoimmune Reaction
|
5.3%
3/57 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
19.3%
11/57 • Number of events 18 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.0%
4/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.3%
11/57 • Number of events 28 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Cardiac General-Other
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Cardiac Troponin I
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypercholesteremia
|
22.8%
13/57 • Number of events 20 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Confusion
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Constipation
|
42.1%
24/57 • Number of events 34 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Constitutional Symptoms
|
3.5%
2/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.6%
14/57 • Number of events 18 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Creatine Phosphokinase
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Creatinine
|
61.4%
35/57 • Number of events 104 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Creatinine Increased
|
3.5%
2/57 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Renal and urinary disorders
Cystitis
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Dehydration
|
8.8%
5/57 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Depression
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
15.8%
9/57 • Number of events 10 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Diarrhea
|
57.9%
33/57 • Number of events 170 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Dizziness
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Xerostomia
|
1.8%
1/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.3%
3/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Dysesthesia
|
1.8%
1/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
3/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
52.6%
30/57 • Number of events 65 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Edema: Head and Neck
|
8.8%
5/57 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
33.3%
19/57 • Number of events 37 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Edema
|
3.5%
2/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Fatigue
|
91.2%
52/57 • Number of events 311 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Fever
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Gamma-Glutamyl Transpeptidase
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.4%
23/57 • Number of events 68 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Alopecia (scalp or body)
|
19.3%
11/57 • Number of events 16 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Headache
|
17.5%
10/57 • Number of events 15 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Heartburn
|
26.3%
15/57 • Number of events 29 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hemoglobin
|
91.2%
52/57 • Number of events 212 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Vascular disorders
Hemorrhage, GI
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Vascular disorders
Hemorrhage, GU
|
5.3%
3/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Vascular disorders
Hemorrhage, Pulmonary/Upper Respiratory
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Vascular disorders
Hemorrhage/Bleeding-Other
|
12.3%
7/57 • Number of events 15 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
3.5%
2/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.5%
6/57 • Number of events 9 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Hypertension
|
61.4%
35/57 • Number of events 78 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
28.1%
16/57 • Number of events 23 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
21.1%
12/57 • Number of events 16 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
1/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.8%
9/57 • Number of events 19 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.0%
8/57 • Number of events 27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Hypotension
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Infections and infestations
Infection
|
5.3%
3/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Infections and infestations
Infection-Other
|
8.8%
5/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Insomnia
|
3.5%
2/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Left Ventricular Diastolic Dysfunction
|
5.3%
3/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Leukocytes
|
70.2%
40/57 • Number of events 172 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Lipase
|
15.8%
9/57 • Number of events 12 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.0%
4/57 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Memory Impairment
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Mood Alteration
|
12.3%
7/57 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
71.9%
41/57 • Number of events 139 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder - Other
|
1.8%
1/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Nausea
|
71.9%
41/57 • Number of events 149 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Endocrine disorders
Neuroendocrine: ACTH Deficiency
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Neuropathy: Motor
|
12.3%
7/57 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Neuropathy: Sensory
|
33.3%
19/57 • Number of events 54 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Neutrophils/Granulocytes
|
42.1%
24/57 • Number of events 119 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Pain in Extremity
|
5.3%
3/57 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Pain-Other
|
66.7%
38/57 • Number of events 157 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Abdominal Pain
|
19.3%
11/57 • Number of events 23 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
22.8%
13/57 • Number of events 21 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Chest Pain
|
5.3%
3/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Face Pain
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Oral Pain
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Musculoskeletal and connective tissue disorders
Scalp Pain
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Throat Pain
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Endocrine disorders
Hypoparathyroidism
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.8%
9/57 • Number of events 13 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Platelets
|
54.4%
31/57 • Number of events 63 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.8%
5/57 • Number of events 15 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Proteinuria
|
28.1%
16/57 • Number of events 26 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
3/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Cardiac disorders
Pulmonary Hypertension
|
1.8%
1/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.5%
2/57 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Skin and subcutaneous tissue disorders
Rash: Hand-Foot Skin Reaction
|
38.6%
22/57 • Number of events 59 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Renal and urinary disorders
Renal Failure
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Serum Glutamic Oxaloacetic Transaminase
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Metabolism and nutrition disorders
Serum Glutamic Pyruvic Transaminase
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Small/Large intestine
|
3.5%
2/57 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Nervous system disorders
Syncope
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Sweating
|
3.5%
2/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Taste Alteration
|
31.6%
18/57 • Number of events 26 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
1.8%
1/57 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Vascular disorders
Thrombosis
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Endocrine disorders
Hypothyroidism
|
8.8%
5/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Eye disorders
Blurred Vision
|
8.8%
5/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Eye disorders
Flashing Lights/Floaters
|
1.8%
1/57 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
7.0%
4/57 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Gastrointestinal disorders
Vomiting
|
49.1%
28/57 • Number of events 85 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
Eye disorders
Watery Eye
|
28.1%
16/57 • Number of events 32 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
|
General disorders
Weight Loss
|
7.0%
4/57 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from administration of study drug on day 1 of course 1 and on day 1 of all subsequent courses, up to 5 years.
Overall collection period: March 2007 to February 2015.
|
Additional Information
Nizar M Tannir, MD, Professor, Genitourinary Medical Oncology
The University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place