Trial Outcomes & Findings for BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC (NCT NCT00410189)
NCT ID: NCT00410189
Last Updated: 2015-03-23
Results Overview
The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline to 8 Weeks
Results posted on
2015-03-23
Participant Flow
Recruitment period: November 2006 to February 2010. All participants recruited at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
ZD6474
ZD6474 300 mg by mouth daily.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC
Baseline characteristics by cohort
| Measure |
ZD6474
n=54 Participants
ZD6474 300 mg by mouth daily.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Age, Customized
<=50 years
|
11 participants
n=5 Participants
|
|
Age, Customized
Between 51 and 60 years
|
15 participants
n=5 Participants
|
|
Age, Customized
Between 61 and 70 years
|
19 participants
n=5 Participants
|
|
Age, Customized
>70 years
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 WeeksThe disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
ZD6474
n=54 Participants
ZD6474 300 mg by mouth daily.
|
|---|---|
|
8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: Every 8 weeks till disease progression.Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.
Outcome measures
| Measure |
ZD6474
n=54 Participants
ZD6474 300 mg by mouth daily.
|
|---|---|
|
8 Week Progression-Free Survival
|
1.81 months
Interval 0.16 to 23.46
|
Adverse Events
ZD6474
Serious events: 54 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZD6474
n=54 participants at risk
ZD6474 300 mg by mouth daily.
|
|---|---|
|
Infections and infestations
Febrile Neutropenia
|
11.1%
6/54 • Number of events 6 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Respiratory Infection
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Lipase Abnormal
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Vascular disorders
Multifold Ischemic Disease of CNS
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin Hemorrhage
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Blood Creatinine Increased
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Renal and urinary disorders
Acute Renal Failure
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Bradycardia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Cardiorespiratory Arrest
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Renal and urinary disorders
Renal Failure
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Neutropenia
|
14.8%
8/54 • Number of events 8 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Dysgeusia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Oesophageal Varices Hemorrhage
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Bronchitis Bacterial
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Eye disorders
Perforated Right Cornea
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Depressed Level of Consciousness
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Cardiac Failure
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Pulmonary Hypertension
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Cerebral Hemorrhage
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Hematocrit Decreased
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Gait Distrubance
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.8%
8/54 • Number of events 8 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Opportunistic Infection
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Sinus Bradycardia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Epistaxis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Hydrocephalus
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Septic Shock
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Death
|
18.5%
10/54 • Number of events 10 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Vascular disorders
Papilloedema
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Vascular disorders
Retinal Artery Occlusion
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Appendicitis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Convulsion
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Influenza
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Pancreatitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Purulent Bronchitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Thromboplastin
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Infection
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Post Operative Wound Infection
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Intestinal Infection
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Urinary Tract Infection
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Pericardial Effusion
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Psychiatric disorders
Cognitive Disorder
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Cardiac Troponin
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Bartholin Abscess
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Perforated Diverticulum
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Encephalopathy
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Hemoptysis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Chest Pain
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Syndrome
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Psychiatric disorders
Hallucinations
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Tumor Hemorrhage
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Thrombolysis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Pulmonary Edema
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Immune system disorders
Sepsis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Edema Peripheral
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Proctorrhagia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Syncope
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
General Physical Health Deterioration
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Seizure
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Gamma-glutamyl transferase
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Anemia
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Pleuropericarditis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Anal Fissure
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Colovesical Fistula
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Investigations
Drug Interaction
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Diabetic Hyperglycemic Coma
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.9%
1/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Vascular disorders
Vasculitis Cerebral
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Epilepsy
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Wound Complication
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Abdominal Perforation
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
PAS Chronic
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Facial Swelling
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
Other adverse events
| Measure |
ZD6474
n=54 participants at risk
ZD6474 300 mg by mouth daily.
|
|---|---|
|
Renal and urinary disorders
Abnormal Electrolytes
|
46.3%
25/54 • Number of events 25 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Constitutional Symptoms
|
44.4%
24/54 • Number of events 24 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
24/54 • Number of events 24 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated Alkaline Phosphatase
|
40.7%
22/54 • Number of events 22 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Hepatobiliary disorders
Abnormal Liver Enzymes
|
35.2%
19/54 • Number of events 19 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Hypertension
|
33.3%
18/54 • Number of events 18 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
11/54 • Number of events 11 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Anorexia
|
27.8%
15/54 • Number of events 15 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.8%
15/54 • Number of events 15 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Pain
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.9%
14/54 • Number of events 14 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal Complaint
|
24.1%
13/54 • Number of events 13 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Infection
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Renal and urinary disorders
Renal Insufficiency
|
22.2%
12/54 • Number of events 12 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Anemia
|
25.9%
14/54 • Number of events 14 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
20.4%
11/54 • Number of events 11 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Bleed
|
18.5%
10/54 • Number of events 10 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.5%
10/54 • Number of events 10 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Abdominal Bloating
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Abdominal Cramps
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Allergies
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Arrythmia, Tachycardia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Arrythmia,PAC's
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Arrythmia,Tachycardia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Ataxia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Bleeding Gums
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Brusing
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Cardiac Ischemic
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Central Nervous System Hemorrhage
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Chills
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Confusion
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Constitutional Cold Sensitive
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Decreased Chloride
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Renal and urinary disorders
Decreased GFR
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Dehydration
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Depression
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Eye disorders
Diplopia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Dizziness
|
11.1%
6/54 • Number of events 6 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Eye disorders
Dry Eye Syndrome
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Dysgeusia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Dysphasia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.5%
10/54 • Number of events 10 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Edema, Bilateral Ankles
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Edema, Left Neck
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Elevated Troponin
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated ALT
|
29.6%
16/54 • Number of events 16 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated Amylase
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated AST
|
31.5%
17/54 • Number of events 17 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated Creatine
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated Creatinine
|
20.4%
11/54 • Number of events 11 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated Glucose
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Elevated INR
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Elevated Lipase
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Elevated Prothrombin Time
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Elevated Partial Thromboplastin Time
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Elevated WBC
|
11.1%
6/54 • Number of events 6 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Epistaxis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Fatigue
|
37.0%
20/54 • Number of events 20 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Fever
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Endocrine disorders
Hot Flashes
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.0%
7/54 • Number of events 7 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
6/54 • Number of events 6 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.0%
7/54 • Number of events 7 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
9/54 • Number of events 9 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
12/54 • Number of events 12 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Hypotension
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Endocrine disorders
Hypothyroidism
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Infection, Ear
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Infection, Eyes
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Infection, Respiratory
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Infection, Toenail
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Insomnia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Lymphopenia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
8/54 • Number of events 8 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Pain, Abdominal
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Chest
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Heel
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Left Knee and Shin
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Left Scapula
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Lumbar
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Musculoskeletal
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right Ear
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right Foot
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right Side
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Waist to Shoulder
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Right Arm
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Pelvic Ascites
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Progression of Disease NOS
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
QTC Prolongation
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash, Acneiform
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash, Chest
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash, Pubic Area
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash, Hands
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Seizures
|
5.6%
3/54 • Number of events 3 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Immune system disorders
Sepsis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Cardiac disorders
Severe Aortic Insufficiency
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Stomatitis
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Infections and infestations
Tooth Abscess
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Nervous system disorders
Tremors
|
3.7%
2/54 • Number of events 2 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Unsteady Gait
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
11.1%
6/54 • Number of events 6 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Eye disorders
Vision Floaters
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
General disorders
Weight Loss
|
9.3%
5/54 • Number of events 5 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Gastrointestinal disorders
Xerostomia
|
1.9%
1/54 • Number of events 1 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash, Face
|
7.4%
4/54 • Number of events 4 • Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Collection period: January 16, 2007 to April 02, 2010.
|
Additional Information
Anne S. Tsao, MD / Associate Professor, Thoracic/Head & Neck Med Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-6363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place