Trial Outcomes & Findings for Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy (NCT NCT01340495)

Last Updated: 2021-01-05

Results Overview

To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or \> radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.

Recruitment status

UNKNOWN

Study phase

Target enrollment

70 participants

Primary outcome timeframe

From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Proton Radiation Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Overall Study STARTED	70
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Proton Radiation Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton Radiation n=70 Participants Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks

Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.

Outcome measures

Outcome measures
Measure	Proton Radiation n=69 Participants Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event	0 Participants

SECONDARY outcome

Timeframe: From the start of treatment until 3 months after the end of treatment

Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.

Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

Outcome measures

Outcome measures
Measure	Proton Radiation n=69 Participants Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
The Number of Participants With Acute Skin Toxicities	69 Participants

SECONDARY outcome

Timeframe: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.

Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.

The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe * Grade 4: Life-Threatening * Grade 5: Fatal

Outcome measures

Outcome measures
Measure	Proton Radiation n=69 Participants Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Rate and Severity of Radiation Pneumonitis Grade 1	0 Participants
Rate and Severity of Radiation Pneumonitis Grade 2	0 Participants
Rate and Severity of Radiation Pneumonitis Grade 3	0 Participants
Rate and Severity of Radiation Pneumonitis Grade 4	0 Participants
Rate and Severity of Radiation Pneumonitis Grade 5	0 Participants

SECONDARY outcome

Timeframe: From 3 months after the end of treatment up to 5 years

A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of treatment until 5 years post treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of treatment until 5 years post treatment

Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of treatment until 5 years post treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and then 4 and 8 weeks post treatment

Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.

The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.

Outcome measures

Outcome measures
Measure	Proton Radiation n=69 Participants Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy	0 Participants

SECONDARY outcome

Timeframe: from the start of treatment until the time of disease progression, up to 5 years

Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.

Outcome measures

Outcome data not reported

Adverse Events

Proton Radiation

Serious events: 20 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Proton Radiation n=70 participants at risk Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Surgical and medical procedures Surgical and medical procedures - Other, specify	18.6% 13/70 • Number of events 18 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Injury, poisoning and procedural complications Dermatitis radiation	2.9% 2/70 • Number of events 2 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	1.4% 1/70 • Number of events 1 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders - Other, specify	10.0% 7/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Injury, poisoning and procedural complications Seroma	1.4% 1/70 • Number of events 1 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Infections and infestations Skin infection	1.4% 1/70 • Number of events 1 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.

Other adverse events

Other adverse events
Measure	Proton Radiation n=70 participants at risk Radiation therapy with proton beam Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Gastrointestinal disorders Abdominal pain	22.9% 16/70 • Number of events 28 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Investigations Alanine aminotransferase increased	8.6% 6/70 • Number of events 14 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Investigations Alkaline phosphatase increased	7.1% 5/70 • Number of events 11 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Immune system disorders Allergic reaction	7.1% 5/70 • Number of events 8 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.1% 5/70 • Number of events 12 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Alopecia	15.7% 11/70 • Number of events 29 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Blood and lymphatic system disorders Anemia	24.3% 17/70 • Number of events 26 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Metabolism and nutrition disorders Anorexia	10.0% 7/70 • Number of events 8 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Psychiatric disorders Anxiety	40.0% 28/70 • Number of events 97 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Arthralgia	54.3% 38/70 • Number of events 110 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Arthritis	12.9% 9/70 • Number of events 16 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Investigations Aspartate aminotransferase increased	10.0% 7/70 • Number of events 14 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Back pain	32.9% 23/70 • Number of events 67 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Bloating	7.1% 5/70 • Number of events 5 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Eye disorders Blurred vision	14.3% 10/70 • Number of events 20 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Bone pain	18.6% 13/70 • Number of events 21 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Breast pain	24.3% 17/70 • Number of events 37 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Injury, poisoning and procedural complications Bruising	11.4% 8/70 • Number of events 9 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Chest wall pain	60.0% 42/70 • Number of events 124 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Chills	8.6% 6/70 • Number of events 7 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Nervous system disorders Cognitive disturbance	7.1% 5/70 • Number of events 17 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Constipation	11.4% 8/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Cough	34.3% 24/70 • Number of events 35 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Psychiatric disorders Depression	24.3% 17/70 • Number of events 63 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Injury, poisoning and procedural complications Dermatitis radiation	98.6% 69/70 • Number of events 356 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Diarrhea	10.0% 7/70 • Number of events 8 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Nervous system disorders Dizziness	18.6% 13/70 • Number of events 22 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Dry skin	15.7% 11/70 • Number of events 25 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Dysmenorrhea	7.1% 5/70 • Number of events 8 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Dyspareunia	14.3% 10/70 • Number of events 30 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Dysphagia	40.0% 28/70 • Number of events 76 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.9% 9/70 • Number of events 16 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.7% 4/70 • Number of events 5 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Injury, poisoning and procedural complications Fall	12.9% 9/70 • Number of events 18 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Fatigue	95.7% 67/70 • Number of events 459 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Fever	14.3% 10/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	55.7% 39/70 • Number of events 101 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Flank pain	12.9% 9/70 • Number of events 23 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Flatulence	5.7% 4/70 • Number of events 4 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Flu like symptoms	8.6% 6/70 • Number of events 9 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Injury, poisoning and procedural complications Fracture	8.6% 6/70 • Number of events 9 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Gait disturbance	10.0% 7/70 • Number of events 12 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 7/70 • Number of events 11 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Gastrointestinal disorders - Other	7.1% 5/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Nervous system disorders Headache	25.7% 18/70 • Number of events 40 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Vascular disorders Hot flashes	52.9% 37/70 • Number of events 150 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Metabolism and nutrition disorders Hyperglycemia	14.3% 10/70 • Number of events 16 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Vascular disorders Hypertension	12.9% 9/70 • Number of events 27 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Endocrine disorders Hypothyroidism	5.7% 4/70 • Number of events 13 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Psychiatric disorders Insomnia	27.1% 19/70 • Number of events 46 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Irregular menstruation	8.6% 6/70 • Number of events 12 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Irritability	5.7% 4/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	47.1% 33/70 • Number of events 80 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Psychiatric disorders Libido decreased	7.1% 5/70 • Number of events 14 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Infections and infestations Lip infection	5.7% 4/70 • Number of events 5 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Localized edema	21.4% 15/70 • Number of events 27 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Infections and infestations Lung infection	5.7% 4/70 • Number of events 4 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Vascular disorders Lymphedema	20.0% 14/70 • Number of events 53 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Investigations Lymphocyte count decreased	17.1% 12/70 • Number of events 30 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Menorrhagia	7.1% 5/70 • Number of events 7 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	8.6% 6/70 • Number of events 19 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	68.6% 48/70 • Number of events 214 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Myalgia	15.7% 11/70 • Number of events 20 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.9% 9/70 • Number of events 13 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Nausea	25.7% 18/70 • Number of events 23 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Neck pain	18.6% 13/70 • Number of events 27 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	21.4% 15/70 • Number of events 18 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
General disorders Pain	42.9% 30/70 • Number of events 93 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Pain in extremity	32.9% 23/70 • Number of events 77 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Cardiac disorders Palpitations	14.3% 10/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Nervous system disorders Paresthesia	8.6% 6/70 • Number of events 11 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Pelvic pain	8.6% 6/70 • Number of events 9 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Nervous system disorders Peripheral sensory neuropathy	34.3% 24/70 • Number of events 89 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.7% 4/70 • Number of events 5 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Postnasal drip	10.0% 7/70 • Number of events 8 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 5/70 • Number of events 7 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Pruritus	55.7% 39/70 • Number of events 106 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	5.7% 4/70 • Number of events 12 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Renal and urinary disorders Renal and urinary disorders - Other, specify	5.7% 4/70 • Number of events 5 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	8.6% 6/70 • Number of events 8 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	5.7% 4/70 • Number of events 6 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	18.6% 13/70 • Number of events 32 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	87.1% 61/70 • Number of events 254 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Infections and infestations Skin infection	20.0% 14/70 • Number of events 21 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	15.7% 11/70 • Number of events 31 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Respiratory, thoracic and mediastinal disorders Sore throat	20.0% 14/70 • Number of events 19 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	10.0% 7/70 • Number of events 11 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Surgical and medical procedures Surgical and medical procedures - Other, specify	40.0% 28/70 • Number of events 53 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Skin and subcutaneous tissue disorders Telangiectasia	15.7% 11/70 • Number of events 32 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Infections and infestations Upper respiratory infection	17.1% 12/70 • Number of events 17 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Renal and urinary disorders Urinary frequency	7.1% 5/70 • Number of events 5 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Uterine hemorrhage	8.6% 6/70 • Number of events 9 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Vaginal discharge	11.4% 8/70 • Number of events 10 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Reproductive system and breast disorders Vaginal dryness	15.7% 11/70 • Number of events 24 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Infections and infestations Vaginal infection	8.6% 6/70 • Number of events 6 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Gastrointestinal disorders Vomiting	8.6% 6/70 • Number of events 6 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.
Investigations White blood cell decreased	18.6% 13/70 • Number of events 22 • Weekly during radiation treatment; 1, 2, 6, and 12 months post treatment; then yearly up until 5 years after the end of treatment (median duration of follow-up of about 36 months of follow-up at the time of analysis). Serious adverse events were defined as adverse events that were serious, life threatening, or fatal and deemed to be at least possibly related to study treatment. Adverse events categorized as 'Other' were grouped together by organ system due to inconsistent terminology used to specify the 'other' adverse event and to highlight overall adverse event trends.

Additional Information

Shannon MacDonald, MD

Massachusetts General Hospital

Phone: 617-643-7250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place