Trial Outcomes & Findings for Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer (NCT NCT00499031)
NCT ID: NCT00499031
Last Updated: 2015-01-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
At 6 months
Results posted on
2015-01-13
Participant Flow
Participant milestones
| Measure |
Treatment (Cetuximab)
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Cetuximab)
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Improper pre-protocol treatment
|
1
|
|
Overall Study
Required test not done
|
1
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cetuximab)
n=35 Participants
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
|
49.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Age, Customized
30-39 years
|
3 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
16 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
10 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma, Unspecified
|
4 participants
n=5 Participants
|
|
Cell Type
Mixed Epithelial Carcinoma
|
1 participants
n=5 Participants
|
|
Cell Type
Adenosquamous
|
6 participants
n=5 Participants
|
|
Cell Type
Squamous Cell Carcinoma
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Total number of eligible and evaluable participants
Outcome measures
| Measure |
Treatment (Cetuximab)
n=35 Participants
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Progression-free Survival Greater Than 6 Months
No
|
30 participants
|
|
Progression-free Survival Greater Than 6 Months
Yes
|
5 participants
|
PRIMARY outcome
Timeframe: every other cycle for the first 6 months; then every 3 months x 2; then every 6 monthsPopulation: Total number of eligible and evaluable participants
Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Outcome measures
| Measure |
Treatment (Cetuximab)
n=35 Participants
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease
|
11 participants
|
|
Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Disease progression
|
23 participants
|
|
Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Indeterminate
|
1 participants
|
SECONDARY outcome
Timeframe: From study entry until disease progression, death or date of last contact, up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study entry to death or the date of last contact, up to 5 yearsOutcome measures
Outcome data not reported
Adverse Events
Treatment (Cetuximab)
Serious events: 15 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Cetuximab)
n=35 participants at risk
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Vascular disorders
Inr
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Fever
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain - Other
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Back
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
Other adverse events
| Measure |
Treatment (Cetuximab)
n=35 participants at risk
Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Immune system disorders
Rhinitis
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Neutrophils
|
11.4%
4/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Platelets
|
14.3%
5/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Leukocytes
|
28.6%
10/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
74.3%
26/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Weight Gain
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Fever
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Weight Loss
|
14.3%
5/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Fatigue
|
57.1%
20/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Death No Ctcae Term - Death Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Acne
|
37.1%
13/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
65.7%
23/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
22.9%
8/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Endocrine disorders
Hot Flashes
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Heartburn
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Taste Alteration
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Incontinence, Anal
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Stomach
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
11.4%
4/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
15/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Anorexia
|
31.4%
11/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
10/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Nausea
|
48.6%
17/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
7/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Esophagus
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Febrile Neutropenia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
11.4%
4/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Infections and infestations
Inf Unknown Anc: Oral Cavity-Gums
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
11.4%
4/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Ast
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Creatinine
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.1%
6/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Ggt
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Alt
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
14.3%
5/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Bilirubin
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.4%
4/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
10/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
7/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
14/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.1%
13/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
34.3%
12/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Nervous system disorders
Mood Alteration - Depression
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Nervous system disorders
Neuropathy-Sensory
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Nervous system disorders
Neuropathy-Motor
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Eye disorders
Watery Eye
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Eye disorders
Flashing Lights/Floaters
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Eye disorders
Blurred Vision
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain - Other
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Urethra
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Pelvis
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Vagina
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Chest /Thorax Nos
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Head/Headache
|
14.3%
5/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Neck
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Extremity-Limb
|
14.3%
5/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Back
|
20.0%
7/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Joint
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Bone
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Kidney
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Pain Nos
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Stomach
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Abdominal Pain Nos
|
25.7%
9/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Face
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
General disorders
Pain: Muscle
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
6/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.9%
8/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Renal and urinary disorders
Urinary Color Change
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Renal and urinary disorders
Urinary Frequency
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.7%
2/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
2.9%
1/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
8.6%
3/35 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period.
From protocol activation through Sept. 30, 2010, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized for defining and grading specific adverse events reported through the AdEERS system. As of Oct. 1, 2010, CTCAE v 4.0 will be utilized for AE reporting. AEs are reported in ClinicalTrials.gov using CTCAE v3.0.
|
Additional Information
Melissa Leventhal
NRG Oncology Statisics and Data Management Center, Buffalo Office
Phone: 716-845-4030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place