Trial Outcomes & Findings for Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (NCT NCT00569673)

Last Updated: 2018-07-18

Results Overview

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 therapy6

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)

Results posted on

2018-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel Plus Trabectedin Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel Plus Trabectedin n=71 Participants Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Age, Customized	59.3 years STANDARD_DEVIATION 9.2 • n=99 Participants
Age, Customized 40-49 years	10 participants n=99 Participants
Age, Customized 50-59 years	28 participants n=99 Participants
Age, Customized 60-69 years	25 participants n=99 Participants
Age, Customized 70-79 years	7 participants n=99 Participants
Age, Customized 80-89 years	1 participants n=99 Participants
Sex: Female, Male Female	71 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	71 participants n=99 Participants
Cell Type Adenocarcinoma, Unspecified	7 participants n=99 Participants
Cell Type Clear Cell Carcinoma	3 participants n=99 Participants
Cell Type Endometrioid Adenocarcinoma	6 participants n=99 Participants
Cell Type Mixed Epithelial Carcinoma	2 participants n=99 Participants
Cell Type Serous Adenocarcinoma	53 participants n=99 Participants

PRIMARY outcome

Timeframe: every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)

Population: Total number eligible and evaluable

Outcome measures

Outcome measures
Measure	Docetaxel Plus Trabectedin n=71 Participants Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Objective Tumor Response Partial response	21 participants
Objective Tumor Response Stable disease	32 participants
Objective Tumor Response Disease progression	17 participants
Objective Tumor Response Indeterminate	1 participants

PRIMARY outcome

Timeframe: Prior to each cycle and 30 days after the last cycle (average of 5 months)

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	Docetaxel Plus Trabectedin n=71 Participants Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Leukopenia	21 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Thrombocytopenia	7 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Neutropenia	21 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Anemia	5 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Other hematologic	2 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Constitutional	8 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Nausea	6 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Vomiting	7 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Gastrointestinal	11 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Hemorrhage	1 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Infection	10 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Metabolic	10 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Musculoskeletal	3 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Other neurological	2 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Pain	6 Participants
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Pulmonary	2 Participants

SECONDARY outcome

Timeframe: up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel Plus Trabectedin

Serious events: 31 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel Plus Trabectedin n=71 participants at risk Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Ear and labyrinth disorders Tinnitus	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Neutrophils	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Platelets	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Hemoglobin	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Fever	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Death No Ctcae Term - Disease Progression Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Obstruction, Gi - Ileum	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Necrosis, Gi - Colon/Cecum/Appendix	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Ileus	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Dysphagia	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Vomiting	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Dehydration	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Constipation	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Nausea	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Gastrointestinal - Other	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Diarrhea	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gi - Rectum	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gi - Stomach	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gi - Abdomen Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Gr 3 Or 4 Anc: Blood	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Edema: Head And Neck	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Alt	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Dizziness	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Chest /Thorax Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Back	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Dyspnea	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Thrombosis/Thrombus/Embolism	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0

Other adverse events

Other adverse events
Measure	Docetaxel Plus Trabectedin n=71 participants at risk Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS"µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
Immune system disorders Rhinitis	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Ear and labyrinth disorders Otitis Middle Ear	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Ear and labyrinth disorders Hearing (Without Monitoring Program)	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Ear and labyrinth disorders Tinnitus	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Neutrophils	52.1% 37/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Platelets	60.6% 43/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Blood/Bone Marrow - Other	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Leukocytes	56.3% 40/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Lymphopenia	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Edema: Limb	21.1% 15/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Edema: Head And Neck	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Ast	25.4% 18/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Edema: Trunk/Genital	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Blood and lymphatic system disorders Hemoglobin	98.6% 70/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders S/N Arrhythmia: Atrial Fibrillation	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders Palpitations	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders Ventricular Arrhythmia - Tachycardia	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders S/N Arrhythmia: Sinus Tachycardia	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders S/N Arrhythmia: Sinus Bradycardia	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders Hypertension	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders Hypotension	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Cardiac disorders Cardipulmonary Arrest	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders International Normalized Ratio	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Constitutional Symptoms - Other	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Sweating	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Weight Gain	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Fever	14.1% 10/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Weight Loss	11.3% 8/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Rigors/Chills	8.5% 6/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Fatigue	85.9% 61/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Insomnia	14.1% 10/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Nail Changes	8.5% 6/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Injection Site Reaction	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	57.7% 41/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Induration	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Bruising	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Rash	11.3% 8/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Dry Skin	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Flushing	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Skin and subcutaneous tissue disorders Hyperpigmentation	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Endocrine disorders Hot Flashes	8.5% 6/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Gastritis	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Esophagitis	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Heartburn	12.7% 9/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Ascites	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Dysphagia	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Distention	8.5% 6/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Taste Alteration	29.6% 21/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Incontinence, Anal	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Dry Mouth	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	15.5% 11/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	8.5% 6/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Vomiting	49.3% 35/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Anorexia	46.5% 33/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Dehydration	12.7% 9/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Constipation	45.1% 32/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Nausea	73.2% 52/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Gastrointestinal disorders Diarrhea	56.3% 40/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gu - Urinary Nos	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gu - Vagina	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gi - Rectum	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage/Pulmonary - Nose	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hematoma	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Vascular disorders Hemorrhage, Gi - Abdomen Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	11.3% 8/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Colitis, Infectious (Eg.C. Difficile)	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Vagina	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf Unknown Anc: Bladder (Urinary)	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Gr 3 Or 4 Anc: Pharynx	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Infections and infestations Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Gfr	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Metabolic/Laboratory - Other	8.5% 6/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Cholesterol,serum High	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Proteinuria	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hemoglobinuria	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Creatinine	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypoalbuminemia	19.7% 14/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Ggt	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Alt	32.4% 23/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Alkaline Phosphatase	25.4% 18/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Bilirubin	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Lipase	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypermagnesemia	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypophosphatemia	9.9% 7/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hyponatremia	15.5% 11/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hyperuricemia	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Cpk	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Bicarbonate, Serum-Low	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypernatremia	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypocalcemia	26.8% 19/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hyperkalemia	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hyperglycemia	31.0% 22/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypokalemia	25.4% 18/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypercalcemia	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Metabolism and nutrition disorders Hypomagnesemia	22.5% 16/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Musculoskeletal and connective tissue disorders Musculoskeletal/St: Other	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	12.7% 9/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	9.9% 7/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Involuntary Movement	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Neurology - Other	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Mood Alteration - Depression	14.1% 10/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Mood Alteration - Anxiety	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Mood Alteration - Agitation	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Tremor	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Irritability	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Somnolence	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Ataxia	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Confusion	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Memory Impairment	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Dizziness	15.5% 11/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Neuropathy-Sensory	46.5% 33/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Nervous system disorders Neuropathy-Motor	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Eye disorders Ocular/Visual - Other	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Eye disorders Dry Eye	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Eye disorders Flashing Lights/Floaters	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Eye disorders Blurred Vision	15.5% 11/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Eye disorders Eyelid Dysfunction	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain - Other	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Urethra	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Chest /Thorax Nos	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Chest Wall	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Throat/Pharynx/Larynx	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Head/Headache	22.5% 16/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Extremity-Limb	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Back	15.5% 11/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Joint	9.9% 7/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Bone	9.9% 7/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Bladder	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Pain Nos	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Rectum	4.2% 3/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Abdominal Pain Nos	31.0% 22/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Cardiac/ Heart	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Tumor	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Liver	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
General disorders Pain: Muscle	9.9% 7/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Nasal/Paranasal Reactions	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Voice Changes	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Cough	18.3% 13/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Respiratory, thoracic and mediastinal disorders Dyspnea	38.0% 27/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Renal/Genitourinary - Other	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Cystitis	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Urinary Retention	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Urinary Electrolyte Wasting	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Incontinence, Urinary	5.6% 4/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Renal Failure	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Renal and urinary disorders Urinary Frequency	7.0% 5/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Reproductive system and breast disorders Libido	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Reproductive system and breast disorders Vaginal Dryness	2.8% 2/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0
Reproductive system and breast disorders Vaginal Discharge	1.4% 1/71 • From study entry until disease progression or study withdrawal. Patients will then be monitored for delayed toxicity for a 5 year period. Activation through Mar 31, 2011, 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. Beginning Apr 1, 2011, CTCAE v 4.0 will be utilized for AE reporting through the AdEERS system. AEs are reported here using only CTCAEv3.0

Additional Information

Jessalyn Reboy

NRG Oncology, Statistics and Data Management Center, Buffalo Office

Phone: 716-845-7738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place