Trial Outcomes & Findings for BATTLE Program: Sorafenib in Patients With NSCLC (NCT NCT00411671)
NCT ID: NCT00411671
Last Updated: 2016-02-11
Results Overview
The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references 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
105 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2016-02-11
Participant Flow
Recruitment period: November 2006 to February 2010. All participants recruited at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Sorafenib 400 mg
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Overall Study
STARTED
|
105
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Sorafenib 400 mg
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
15
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
BATTLE Program: Sorafenib in Patients With NSCLC
Baseline characteristics by cohort
| Measure |
Sorafenib 400 mg
n=105 Participants
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Age, Customized
< 60 years
|
43 participants
n=5 Participants
|
|
Age, Customized
>= 60 years
|
62 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksPopulation: Of the enrolled participants, 98 were evaluable for the outcome.
The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Sorafenib 400 mg
n=98 Participants
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
8-Week Disease Control Rate
|
58.2 percentage of participants
|
SECONDARY outcome
Timeframe: From date of randomization until PD or death respectively, up to 3 yearsPopulation: Of the enrolled participants, only 98 were evaluable for the outcome.
The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.
Outcome measures
| Measure |
Sorafenib 400 mg
n=98 Participants
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Progression-Free Survival
|
2.83 months
Interval 1.87 to 3.55
|
SECONDARY outcome
Timeframe: At baseline and then every 8 weeks until treatment discontinuation.Population: Of the enrolled participants, only 98 were evaluable for the outcome.
Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Sorafenib 400 mg
n=98 Participants
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Tumor Response Measured Every 8-weeks
Stable Disease
|
57 participants
|
|
Tumor Response Measured Every 8-weeks
Patial Response
|
0 participants
|
|
Tumor Response Measured Every 8-weeks
Progressive Disease
|
36 participants
|
|
Tumor Response Measured Every 8-weeks
Early Progression
|
5 participants
|
Adverse Events
Sorafenib 400 mg
Serious events: 105 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib 400 mg
n=105 participants at risk
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hydronephrosis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Stroke
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Central Retinal Vein Occlusion
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Myocardial Infarction
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Transient Ischaemic Attack
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Eye disorders
Ulcerative Keratitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Induration
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Necrosis of a Pleural Metastasis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural Fistula
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Variceal Haemorrhage
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Multi Organ Failure
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Chills
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Urinary Retention
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Cerebral Seizure
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Duodenitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Cancer of Lung
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Cerebrovascular ischemia
|
4.8%
5/105 • Number of events 5 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Death
|
15.2%
16/105 • Number of events 16 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Ruptured Graft
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Perforated Gastric Ulcer
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Psychiatric disorders
Mental Status Changed
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Acute Deterioration of General Health
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Cardiac Troponin
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Itchy Reddened Skin
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Mild Swelling of the Finger Joints
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Bladder Perforation
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Pain, Breast Area
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Reproductive system and breast disorders
Scrotal Abscess
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Hypotonic
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Hypovolemic
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Paroxysmal Supraventricular Tachycardia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Non Functioning Right Kidney
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Perinephric Abscess
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Generalized Oedema
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Decompensation Hydroelectrolytic
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Confusion
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Hypotension
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
3/105 • Number of events 3 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Tenesmus
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Anal Pain
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Inflammed Caecum
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Renal Failure
|
7.6%
8/105 • Number of events 8 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Reproductive system and breast disorders
Bartholin Cyst
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Abdominal Abscess
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Groin Abscess
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Herpes Zoster
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Hand Foot Syndrome
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Ejection Fraction
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Immune system disorders
Septic Shock
|
2.9%
3/105 • Number of events 3 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Fatal Rhabdomyolysis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Hepatic Failure
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fatal Disseminated Intravasular Coagulation
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Melasma
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Partial Thromboplastin Time Increased
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Bruising of Left Extremity
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Tetany
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Cellulitis
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
General Physical Health Deterioration
|
2.9%
3/105 • Number of events 3 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Proximal Myopathy
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Toxicoderma
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Epigastralgia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinomatous Peritonitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Liver Carcinoma Ruptured
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Eye disorders
Hemianopsia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Endocrine disorders
ADH Secretion Abnormality
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Neuropathy
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Agitation
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Cadiogenic Shock
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Chest Pain
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Interstitial Infiltrates
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Fatal Pancytopenia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Mucositis
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Fatal Pustulosis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Oversedation from Oxycontin
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Pseudomonas Stutzeri Sepsis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Klebsiella Sepsis
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Immune system disorders
Sepsis
|
5.7%
6/105 • Number of events 6 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Failure to Thrive
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
4/105 • Number of events 4 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Left Hemiparesis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Loss of Consciousness
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Rupture of Hepatocellular Carcinoma
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Somnolence
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Cognitive Disturbance
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
General Health Degradation
|
4.8%
5/105 • Number of events 5 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Drowsiness
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
3.8%
4/105 • Number of events 4 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Volume Depletion
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Acute Renal Insufficiency
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Colon Perforation
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Peritonitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Endocrine disorders
Acute Pancreatitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Fatal Cardiopulmonary Decompensation
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Paralytic Ileus
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Pericardial Effusion
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Streptococcus Positive
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Transient Troponin I elevated
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Perianal Abscess
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Hepatic Function Disorder
|
3.8%
4/105 • Number of events 4 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Vasculitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
LDH Increased
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
GGTP Increased
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Ulcerative Colitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Thromboembolism
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Erosive Gastropathy
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Gastric Angiodysplasia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Clostridium Difficile
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Liver Failure
|
2.9%
3/105 • Number of events 3 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Jaundice
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Heart Insufficiency
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Edema
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Aplastic Bone Marrow
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Gout Attack
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Ankle Arthritis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
4.8%
5/105 • Number of events 5 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Fatal Cardiac Arrest
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Fatal Ischemic Heart Disease
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Collapse
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Retinal Vein Thrombosis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.8%
4/105 • Number of events 4 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Syncope
|
3.8%
4/105 • Number of events 5 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Rectal Ulcer
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Coma
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Ataxia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Dizziness
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Ear and labyrinth disorders
Hearing Loss
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thromboembolism
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Thrombosis Pain
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Edema
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Pericarditis Constrictive
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Anemia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Function Liver Abnormal
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Fatigue
|
4.8%
5/105 • Number of events 5 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Esophagitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
3.8%
4/105 • Number of events 4 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Fatal Subdural Bleeding
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Fatal Brain Edema
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Neutropenia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Colitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Vertigo
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Fever
|
1.9%
2/105 • Number of events 2 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Hepatic Infarction
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Cholangitis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Erythropoiesis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Hepatic Necrosis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Portal Vein Thrombosis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
Liver Hemorrhage
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Hepatobiliary disorders
CRP Increased
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Bradycardia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Tachycardia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Altered State of Consciousness
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Infections and infestations
Periapical Abscess
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Pneumatosis Intestinalis with Pneumoperitoneum
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Cavitation of Pulmonary Hilar Mass
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Reproductive system and breast disorders
Enterovaginal Fistula
|
0.95%
1/105 • Number of events 1 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
Other adverse events
| Measure |
Sorafenib 400 mg
n=105 participants at risk
Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Anorexia
|
4.8%
5/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Bilirubin
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Constipation
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Dehydration
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Diarrhea
|
7.6%
8/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.9%
3/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Elevated LDH
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiform
|
8.6%
9/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Fatigue
|
8.6%
9/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Fever Unknown Origin
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Fever Without Neutropenia
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Musculoskeletal and connective tissue disorders
Hand-Foot Syndrome
|
14.3%
15/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Renal and urinary disorders
Hematuria
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hemoglobin
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Hypertension
|
4.8%
5/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.8%
4/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Hypotension
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Metabolism and nutrition disorders
Metabolic Laboratory
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Mood Alteration
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Mucositis
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
5/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Nausea Alone
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Neutrophils
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Eye disorders
Ocular Surface Disease
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Cardiac disorders
Pain (Chest Wall)
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Nervous system disorders
Pain (Head/Headache)
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Pain (NOS)
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Pain (Oral Cavity)
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Petechiae
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Blood and lymphatic system disorders
Platelets
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Sore Throat
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
Gastrointestinal disorders
Stomatitis
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Syndromes (other)
|
0.95%
1/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
|
General disorders
Taste Alteration
|
1.9%
2/105 • Adverse events will be recorded for all patients from the time of consent until 30 days following the last dose of study treatment.
Collection period: December 18, 2006 to November 13, 2010.
|
Additional Information
George Blumenschein, MD / Professor, Thoracic/Head & Neck Med Oncology
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