Trial Outcomes & Findings for Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer (NCT NCT00369122)

Last Updated: 2018-03-20

Results Overview

Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Grade (Gr) \>= 4 vaginal bleeding, Gr \>=4 thrombotic event, Gr \>=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for \>2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for \>7 days, febrile neutropenia defined as a temperature \>38.5 degree Celsius and granulocytes \< 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

From start of treatment to 90 days.

Results posted on

2018-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Overall Study STARTED	60
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Overall Study Ineligible	10
Overall Study No protocol treatment	1

Baseline Characteristics

Bevacizumab, Radiation Therapy, and Cisplatin in Treating Patients With Previously Untreated Locally Advanced Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=60 Participants Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Age, Continuous	45.5 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment to 90 days.

Population: Eligible patients who began study treatment.

Outcome measures

Outcome measures
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=49 Participants Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start. Serious Adverse Events	0 participants
Number of Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start. Adverse Events	15 participants

SECONDARY outcome

Timeframe: From start of treatment to last follow-up, up to 6.0 years. Analysis occurred after all patients had been on study for at least 2 years.

Population: Eligible patients who started study treatment

Adverse events (AEs) graded using CTCAE v3.0. Grade (Gr) refers to the severity of the AE and assigns Gr 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1= Mild AE, 2= Moderate AE, 3= Severe AE, 4= Life-threatening or disabling AE, 5= Death related to AE. Treatment-related SAEs defined as Gr \>= 4 vaginal bleeding, Gr \>=4 thrombotic event, Gr \>=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for \>2 weeks despite medical intervention, Gr 4 neutropenia or leukopenia persisting for \>7 days, febrile neutropenia defined as a temperature \>38.5 degree Celsius and granulocytes \< 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs.

Outcome measures

Outcome measures
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=49 Participants Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time. Serious Adverse Events	0 participants
Number of Subjects With Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time. Adverse Events	18 participants

SECONDARY outcome

Timeframe: From registration to 3 years

Population: Eligible patients who started study treatment

Failure is defined as local, regional, or distant disease, or death due to any cause. Disease-free survival time is defined as time from registration to the date of failure and disease-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive and disease-free are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=49 Participants Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Disease-free Survival (Three-year Rate Reported)	68.7 percentage of participants Interval 53.5 to 79.8

SECONDARY outcome

Timeframe: From registration to 3 years

Population: Eligible patients who started study treatment

Overall survival time is defined as time from registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=49 Participants Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.
Overall Survival (Three-year Rate Reported)	81.3 percentage of participants Interval 67.2 to 89.8

Adverse Events

Treatment (Radiation Therapy, Bevacizumab, Cisplatin)

Serious events: 13 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=59 participants at risk Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35. Data is reported for all patients who received study treatment, which is 59 patients.
Blood and lymphatic system disorders Febrile neutropenia	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Diarrhea	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Nausea	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Proctitis	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Rectal pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Vomiting	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Fever	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Immune system disorders Allergic reaction	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Bladder infection	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Catheter related infection	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Lung infection	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Injury, poisoning and procedural complications Vascular access complication	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations GGT increased	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Lymphocyte count decreased	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Neutrophil count decreased	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Platelet count decreased	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations White blood cell decreased	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Anorexia	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Dehydration	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hyperglycemia	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypokalemia	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Syncope	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Psychiatric disorders Depression	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Urinary tract obstruction	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Vascular disorders Thromboembolic event	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.

Other adverse events

Other adverse events
Measure	Treatment (Radiation Therapy, Bevacizumab, Cisplatin) n=59 participants at risk Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy. Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning \>= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, \>= 48 hours apart, beginning \>= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35. Data is reported for all patients who received study treatment, which is 59 patients.
Blood and lymphatic system disorders Anemia	54.2% 32/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Ear and labyrinth disorders Hearing impaired	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Ear and labyrinth disorders Tinnitus	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Eye disorders Blurred vision	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Eye disorders Extraocular muscle paresis	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Eye disorders Flashing lights	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Abdominal distension	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Abdominal pain	18.6% 11/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Anal fistula	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Anal pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Colitis	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Constipation	28.8% 17/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Diarrhea	50.8% 30/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Dry mouth	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Dyspepsia	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Dysphagia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Esophagitis	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Gastritis	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Gastrointestinal disorders - Other	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Hemorrhoids	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Mucositis oral	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Nausea	54.2% 32/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Proctitis	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Rectal hemorrhage	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Rectal pain	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Gastrointestinal disorders Vomiting	25.4% 15/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Chills	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Edema limbs	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Fatigue	57.6% 34/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Fever	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders General disorders and administration site conditions - Other	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Non-cardiac chest pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
General disorders Pain	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Infections and infestations - Other	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Sinusitis	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Soft tissue infection	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Urinary tract infection	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Infections and infestations Vaginal infection	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Injury, poisoning and procedural complications Dermatitis radiation	10.2% 6/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Injury, poisoning and procedural complications Ureteric anastomotic leak	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Activated partial thromboplastin time prolonged	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Alanine aminotransferase increased	13.6% 8/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Alkaline phosphatase increased	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Aspartate aminotransferase increased	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Blood bilirubin increased	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Cholesterol high	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Creatinine increased	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Investigations - Other	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Lymphocyte count decreased	28.8% 17/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Neutrophil count decreased	28.8% 17/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Platelet count decreased	44.1% 26/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Weight gain	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations Weight loss	13.6% 8/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Investigations White blood cell decreased	69.5% 41/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Acidosis	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Anorexia	18.6% 11/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Dehydration	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypercalcemia	11.9% 7/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hyperglycemia	28.8% 17/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hyperkalemia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypernatremia	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hyperuricemia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypoalbuminemia	22.0% 13/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypocalcemia	18.6% 11/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypoglycemia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypokalemia	28.8% 17/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypomagnesemia	39.0% 23/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hyponatremia	27.1% 16/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Metabolism and nutrition disorders Hypophosphatemia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Back pain	10.2% 6/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Bone pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Myalgia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Neck pain	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Musculoskeletal and connective tissue disorders Pain in extremity	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Dizziness	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Dysgeusia	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Facial nerve disorder	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Headache	20.3% 12/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Nervous system disorders - Other	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Peripheral motor neuropathy	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Nervous system disorders Peripheral sensory neuropathy	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Psychiatric disorders Agitation	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Psychiatric disorders Anxiety	13.6% 8/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Psychiatric disorders Depression	13.6% 8/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Psychiatric disorders Insomnia	13.6% 8/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Bladder spasm	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Chronic kidney disease	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Cystitis noninfective	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Hemoglobinuria	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Proteinuria	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Renal and urinary disorders - Other	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Urinary frequency	13.6% 8/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Urinary incontinence	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Urinary retention	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Urinary tract obstruction	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Renal and urinary disorders Urinary tract pain	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Irregular menstruation	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Lactation disorder	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Pelvic pain	18.6% 11/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Perineal pain	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Uterine hemorrhage	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Uterine obstruction	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Uterine pain	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal discharge	18.6% 11/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal dryness	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal fistula	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal hemorrhage	42.4% 25/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal inflammation	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal obstruction	10.2% 6/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Reproductive system and breast disorders Vaginal pain	6.8% 4/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 3/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Voice alteration	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Alopecia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Dry skin	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Pruritus	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Rash acneiform	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin hypopigmentation	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin induration	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin ulceration	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Skin and subcutaneous tissue disorders Telangiectasia	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Vascular disorders Flushing	1.7% 1/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Vascular disorders Hot flashes	23.7% 14/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Vascular disorders Hypertension	10.2% 6/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Vascular disorders Hypotension	8.5% 5/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.
Vascular disorders Vascular disorders - Other	3.4% 2/59 Per the protocol, toxicity data was collected via Common Terminology Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given AE are counted only once for that AE.

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60