Trial Outcomes & Findings for Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer (NCT NCT00408694)

Last Updated: 2018-01-30

Results Overview

Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

From start of treatment to one year.

Results posted on

2018-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	46
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Ineligible	1
Overall Study No protocol treatment	1

Baseline Characteristics

Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=46 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Age, Continuous	48 years n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	30 Participants n=93 Participants

PRIMARY outcome

Timeframe: From start of treatment to one year.

Population: Eligible patients who started study treatment.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years.

Population: Eligible patients who started study treatment and survived more than one year.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=41 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From start of treatment to end of treatment (approximately day 109).

Population: Eligible patients who started study treatment

Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen Concurrent component	68.2 percentage of participants Interval 52.4 to 81.4
Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen Adjuvant component	68.2 percentage of participants Interval 52.4 to 81.4

SECONDARY outcome

Timeframe: From start of treatment to 30 days after end of treatment (treatment ends approximately day 109).

Population: Eligible patients who started study treatment

The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Death During or Within 30 Days of Discontinuation of Protocol Treatment.	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From registration to two years

Population: Eligible patients who started study treatment

Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
One- and Two-year Distant Metastases-free Rates One-year	97.7 percentage of participants Interval 93.3 to 100.0
One- and Two-year Distant Metastases-free Rates Two-year	90.8 percentage of participants Interval 82.2 to 99.5

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years.

Population: Eligible patients who started study treatment.

Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
One- and Two-year Loco-regional Progression-free Rates One-year	93.2 percentage of participants Interval 85.6 to 100.0
One- and Two-year Loco-regional Progression-free Rates Two-year	74.7 percentage of participants Interval 61.8 to 87.6

SECONDARY outcome

Population: Eligible patients who started study treatment

Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
One- and Two-year Progression-free Survival Rates One-year	90.9 percentage of participants Interval 82.4 to 99.4
One- and Two-year Progression-free Survival Rates Two-year	74.7 percentage of participants Interval 61.8 to 87.6

SECONDARY outcome

Population: Eligible patients who started study treatment

Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
One- and Two-year Overall Survival Rates One-year	93.2 percentage of participants Interval 85.7 to 100.0
One- and Two-year Overall Survival Rates Two-year	90.9 percentage of participants Interval 82.3 to 99.4

SECONDARY outcome

Timeframe: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years.

Population: Eligible patients who started treatment

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 Participants BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment	90.9 percentage of participants Interval 78.3 to 97.5

Adverse Events

Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)

Serious events: 28 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 participants at risk BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients.
Blood and lymphatic system disorders Anemia	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Febrile neutropenia	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Paroxysmal atrial tachycardia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Sinus tachycardia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Hearing impaired	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Conjunctivitis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Abdominal pain	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Constipation	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Diarrhea	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dysphagia	13.6% 6/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Gastrointestinal disorders - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Mucositis oral	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Nausea	15.9% 7/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Oral pain	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Rectal fistula	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Vomiting	15.9% 7/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Chills	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Fatigue	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Fever	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders General disorders and administration site conditions - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Catheter related infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Infections and infestations - Other	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Lung infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Penile infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Peripheral nerve infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Sinusitis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Injury, poisoning and procedural complications Dermatitis radiation	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Alanine aminotransferase increased	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Aspartate aminotransferase increased	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Blood antidiuretic hormone abnormal	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Lymphocyte count decreased	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Neutrophil count decreased	13.6% 6/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Platelet count decreased	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Weight loss	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations White blood cell decreased	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Acidosis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Anorexia	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Dehydration	20.5% 9/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyperglycemia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypernatremia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypokalemia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyponatremia	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypophosphatemia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Chest wall pain	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Depressed level of consciousness	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Dysgeusia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Neuralgia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Psychiatric disorders Depression	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Reproductive system and breast disorders Erectile dysfunction	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Aspiration	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Hypertension	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Thromboembolic event	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.

Other adverse events

Other adverse events
Measure	Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT) n=44 participants at risk BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions. ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients.
Blood and lymphatic system disorders Anemia	40.9% 18/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Febrile neutropenia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Blood and lymphatic system disorders Hemolysis	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Paroxysmal atrial tachycardia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Cardiac disorders Sinus bradycardia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Ear pain	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders External ear inflammation	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Hearing impaired	45.5% 20/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Middle ear inflammation	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Ear and labyrinth disorders Tinnitus	31.8% 14/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Endocrine disorders Hyperthyroidism	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Endocrine disorders Hypothyroidism	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Blurred vision	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Eye disorders - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Eye disorders Photophobia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Abdominal pain	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Anal mucositis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Constipation	50.0% 22/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dental caries	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Diarrhea	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dry mouth	95.5% 42/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dyspepsia	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Dysphagia	95.5% 42/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Esophageal pain	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Esophagitis	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Gastritis	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Gastrointestinal disorders - Other	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Lip pain	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Mucositis oral	90.9% 40/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Nausea	72.7% 32/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Oral pain	31.8% 14/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Rectal fistula	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Rectal pain	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Toothache	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Gastrointestinal disorders Vomiting	47.7% 21/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Chills	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Edema face	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Edema limbs	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Fatigue	79.5% 35/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Fever	25.0% 11/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders General disorders and administration site conditions - Other	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
General disorders Pain	20.5% 9/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Immune system disorders Allergic reaction	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Gum infection	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Infections and infestations - Other	18.2% 8/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Lung infection	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Peripheral nerve infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Pharyngitis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Sinusitis	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Upper respiratory infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Urinary tract infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Infections and infestations Wound infection	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Injury, poisoning and procedural complications Bruising	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Injury, poisoning and procedural complications Dermatitis radiation	50.0% 22/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	45.5% 20/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Activated partial thromboplastin time prolonged	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Alanine aminotransferase increased	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Alkaline phosphatase increased	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Aspartate aminotransferase increased	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Blood bilirubin increased	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Creatinine increased	15.9% 7/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations GGT increased	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations INR increased	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Investigations - Other	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Lymphocyte count decreased	20.5% 9/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Neutrophil count decreased	31.8% 14/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Platelet count decreased	29.5% 13/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations Weight loss	43.2% 19/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Investigations White blood cell decreased	38.6% 17/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Acidosis	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Anorexia	27.3% 12/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Dehydration	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyperglycemia	31.8% 14/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypernatremia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypertriglyceridemia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypoalbuminemia	31.8% 14/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypocalcemia	15.9% 7/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypokalemia	20.5% 9/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypomagnesemia	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hyponatremia	34.1% 15/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Metabolism and nutrition disorders Hypophosphatemia	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Avascular necrosis	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Myalgia	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Neck pain	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Musculoskeletal and connective tissue disorders Trismus	34.1% 15/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Accessory nerve disorder	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Acoustic nerve disorder NOS	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Cognitive disturbance	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Depressed level of consciousness	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Dizziness	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Dysgeusia	52.3% 23/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Dysphasia	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Extrapyramidal disorder	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Facial muscle weakness	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Headache	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Myelitis	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Nervous system disorders - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Neuralgia	36.4% 16/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Peripheral motor neuropathy	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Peripheral sensory neuropathy	54.5% 24/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Nervous system disorders Tremor	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Psychiatric disorders Anxiety	13.6% 6/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Psychiatric disorders Confusion	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Psychiatric disorders Depression	15.9% 7/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Psychiatric disorders Insomnia	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Psychiatric disorders Psychosis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Renal and urinary disorders Chronic kidney disease	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Renal and urinary disorders Cystitis noninfective	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Renal and urinary disorders Hematuria	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Renal and urinary disorders Urinary frequency	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Renal and urinary disorders Urinary incontinence	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Renal and urinary disorders Urine discoloration	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Reproductive system and breast disorders Irregular menstruation	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Cough	13.6% 6/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Hiccups	6.8% 3/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	22.7% 10/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	18.2% 8/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pharyngeal hemorrhage	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	54.5% 24/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pharyngeal stenosis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	25.0% 11/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Sinus disorder	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Respiratory, thoracic and mediastinal disorders Voice alteration	29.5% 13/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Alopecia	34.1% 15/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Dry skin	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Pruritus	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 4/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin atrophy	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	27.3% 12/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin hypopigmentation	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Skin and subcutaneous tissue disorders Skin induration	45.5% 20/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Flushing	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Hot flashes	4.5% 2/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Hypertension	11.4% 5/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Lymphedema	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
Vascular disorders Thromboembolic event	2.3% 1/44 Per the protocol, toxicity was collected via CTCAE 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given adverse event (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